Therapy Detail

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Therapy Name Olaparib
Synonyms
Therapy Description

Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for treatment of ERBB2 (HER2)-negative breast cancer with deleterious or suspected deleterious germline BRCA mutations, ovarian cancer with deleterious or suspected deleterious germline BRCA mutations and received 3 or more prior therapies, metastatic pancreatic adenocarcinoma with deleterious or suspected deleterious germline BRCA mutations as a maintenance therapy, metastatic castration-resistant prostate cancer (mCRPC) with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, in combination with abiraterone in patients with mCRPC harboring deleterious or suspected deleterious BRCA mutations, as a maintenance therapy in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and in epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutation, and in combination with Avastin (bevacizumab) as maintenance therapy in HDR defective epithelial ovarian, fallopian tube or primary peritoneal cancer as defined by deleterious or suspected deleterious BRCA mutation, and/or genomic instability (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Olaparib Lynparza AZD2281|KU-0059436 PARP Inhibitor (Pan) 30 Lynparza (olaparib) binds to and inhibits PARP, resulting in inhibition of DNA repair and lethality in homologous-recombination deficient cells, and may be a sensitizing agent for chemotherapy and radiotherapy (PMID: 25028150, PMID: 24225019). Lynparza (olaparib) is FDA approved for treatment of ERBB2 (HER2)-negative breast cancer with deleterious or suspected deleterious germline BRCA mutations, ovarian cancer with deleterious or suspected deleterious germline BRCA mutations and received 3 or more prior therapies, metastatic pancreatic adenocarcinoma with deleterious or suspected deleterious germline BRCA mutations as a maintenance therapy, metastatic castration-resistant prostate cancer (mCRPC) with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, in combination with abiraterone in patients with mCRPC harboring deleterious or suspected deleterious BRCA mutations, as a maintenance therapy in recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer and in epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutation, and in combination with Avastin (bevacizumab) as maintenance therapy in HDR defective epithelial ovarian, fallopian tube or primary peritoneal cancer as defined by deleterious or suspected deleterious BRCA mutation, and/or genomic instability (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PALB2 P8L osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 P8L were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
ATM mutant prostate cancer sensitive Olaparib Phase II Actionable In a Phase II clinical trial, 80% (4/5) of metastatic castration-resistant prostate cancer patients with ATM truncation mutations demonstrated response to Lynparza (olaparib) treatment (Cancer Res August 1, 2015 75:CT322). detail...
IDH1 R132H Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing IDH1 R132H demonstrated increased sensitivity to Lynparza (olaparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
ATM T1200Lfs*7 NRAS Q61K TP53 R213* sarcoma predicted - resistant Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in rapid disease progression in a patient with high-grade sarcoma harboring ATM T1200Lfs*7, NRAS Q61K, and TP53 R213* (PMID: 29304353). 29304353
FANCA S1088F prostate cancer predicted - sensitive Olaparib Preclinical - Pdx Actionable In a preclinical study, overexpression of FANCA S1088F in FANCA-null cells derived from Fanconi anemia patients resulted in increased sensitivity to Lynparza (olaparib) in culture, and a patient-derived xenograft (PDX) model of prostate cancer harboring germline FANCA S1088F demonstrated enhanced sensitivity to Lynparza (olaparib) treatment (PMID: 28864460). 28864460
RAD51C T132R Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C T132R sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C G302V Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G302V sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C A279P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C A279P sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM del lung non-small cell carcinoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of ATM knockout non-small cell lung carcinoma cells in culture (PMID: 31699977). 31699977
PALB2 Q988* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 Q988* in culture (PMID: 31757951). 31757951
PALB2 E669fs Advanced Solid Tumor predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 E669fs in culture (PMID: 31757951). 31757951
FANCL inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in FANCL (NCCN.org). detail...
FANCL inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including FANCL (PMID: 32343890; NCT02987543). detail... detail... 32343890
ATRX loss high grade glioma predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of immortalized astrocytes with loss of ATRX in culture (PMID: 34118569). 34118569
ARID1A Q456* colorectal cancer sensitive Olaparib Preclinical Actionable In a preclinical study, Lynparza (olaparib) inhibited proliferation and colony formation of a colorectal cancer cell line harboring ARID1A Q456* in culture (PMID: 26069190). 26069190
RAD51C D159A Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C D159A sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in RAD51C (NCCN.org). detail...
RAD51C inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51C (PMID: 32343890; NCT02987543). detail... detail... 32343890
CHEK2 mutant breast cancer no benefit Olaparib Case Reports/Case Series Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment did not result in an objective response in 7 patients with metastatic breast cancer harboring only germline mutations in CHEK2 (PMID: 33119476; NCT03344965). 33119476
DNMT3A del acute myeloid leukemia resistant Olaparib Preclinical - Cell culture Actionable In a preclinical study, mouse acute myeloid leukemia cells harboring a DNMT3A deletion along with FLT3-ITD mutation were resistant to Lynparza (olaparib) in culture (PMID: 34215619). 34215619
RAD51C R193L ovarian carcinoma resistant Olaparib Preclinical - Cell culture Actionable In a preclinical study, ovarian carcinoma cells expressing RAD51C R193L demonstrated resistance to Lynparza (olaparib) in culture (PMID: 28588062). 28588062
PALB2 L1027R Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 L1027R conferred sensitivity to Lynparza (olaparib)-induced growth inhibition in TP53 and PALB2 double knock-out mouse embryonic stem cells in culture (PMID: 33811135). 33811135
PALB2 L1070P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 L1070P were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased cell survival (PMID: 31636395). 31636395
ATM V1841I neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm V1841I, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
IDH1 R132C cholangiocarcinoma no benefit Olaparib Preclinical - Pdx & cell culture Actionable In a preclinical study, cholangiocarcinoma patient-derived xenograft (PDX) cell lines harboring IDH1 R132C were insensitive to Lynparza (olaparib) in culture and did not inhibit tumor growth in the patient-derived xenograft (PDX) model (PMID: 36374558). 36374558
PALB2 L35P PALB2 Y551* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 L35P sensitized transformed human cells harboring PALB2 Y551* to Lynparza (olaparib) treatment in culture (PMID: 35853885). 35853885
RAD51C D242N Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C D242N sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM L1874F neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm L1874F, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
PALB2 inact mut Her2-receptor negative breast cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in the Pan-Asian Guidelines Adaptation (PAGA) as second-line therapy for patients with hormone receptor-positive, ERBB2 (HER2)-negative metastatic breast cancer with germline pathogenic/likely pathogenic PALB2 mutations who have progressed on an endocrine therapy plus CDK4/6 inhibitor (PMID: 37178669; ESMO.org). 37178669 detail...
PALB2 Y551* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 Y551* in culture (PMID: 31757951). 31757951
RAD51C G162E Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G162E sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C loss stomach cancer sensitive Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, RAD51C-deficient gastric cancer cells demonstrated increased sensitivity to Lynparza (olaparib) compared to cells over expressing RAD51C, and Lynparza (olaparib) treatment inhibited tumor growth in RAD51C-deficient gastric cancer cell line xenograft models (PMID: 23512992). 23512992
PTEN negative endometrial carcinoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment did not significantly increase DNA damage or inhibit growth of PTEN-deficient endometrial carcinoma cell lines in culture (PMID: 28945226). 28945226
PALB2 A38V Advanced Solid Tumor no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 A38V did not confer sensitivity to Lynparza (olaparib)-induced growth inhibition in TP53 and PALB2 double knock-out mouse embryonic stem cells in culture (PMID: 33811135). 33811135
ATM S1905Ifs*25 gallbladder carcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, treatment with Lynparza (olaparib) resulted in improved clinical symptoms and progression-free survival of 13 months in a patient with gallbladder carcinoma harboring ATM S1905Ifs*25 (PMID: 32045060). 32045060
TET2 loss acute myeloid leukemia sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) inhibited colony formation in mouse acute myeloid leukemia cells harboring TET2 loss along with various oncogenic tyrosine kinase mutations in culture (PMID: 34215619). 34215619
PALB2 L35P osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 L35P were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
RAD51C D159Y Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C D159Y sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM L1449* prostate adenocarcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in stable disease for more than 6 months in a patient with prostate adenocarcinoma harboring ATM L1449*, amplification of AR, MYC, BCL9, MCL1, MDM4, RPS6KB1, APEX1, PNP, ATP11B, and DCUN1D1, and a TMPRSS2-ERG fusion (PMID: 29304353). 29304353
PALB2 P8L Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 P8L were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
RAD51C G130R Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G130R sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C R168G osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C R168G sensitized RAD51C-null osteosarcoma cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell survival (PMID: 37253112). 37253112
ATM R2691C neuroblastoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of transformed neuroblastoma cells expressing ATM R2691C resulted in similar cell viability levels to wild-type Atm in culture (PMID: 29059438). 29059438
PALB2 A1025R Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 A1025R were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased cell survival (PMID: 31636395). 31636395
RAD51C R237P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C R237P sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C L138F Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C L138F sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C T132I Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C T132I sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
DNMT3A loss acute myeloid leukemia resistant Olaparib Preclinical - Cell culture Actionable In a preclinical study, mouse acute myeloid leukemia cells harboring DNMT3A loss along with various oncogenic tyrosine kinase mutations were resistant to Lynparza (olaparib) in culture (PMID: 34215619). 34215619
RAD51C L27P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C L27P sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM S1455R neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm S1455R, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
PALB2 L24S Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 L24S were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased cell survival (PMID: 31636395). 31636395
PALB2 I944N Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 I944N were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased cell survival (PMID: 31636395). 31636395
PALB2 Y409* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 Y409* in culture (PMID: 31757951). 31757951
RAD51C R193W ovarian carcinoma resistant Olaparib Preclinical - Cell culture Actionable In a preclinical study, ovarian carcinoma cells expressing RAD51C R193W demonstrated resistance to Lynparza (olaparib) in culture (PMID: 28588062). 28588062
PALB2 T1030I osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 T1030I were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
IDH1 R132C chondrosarcoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Lynparza (olaparib) treatment resulted in a partial response with 59% tumor reduction lasting 14 months in one patient and stable disease lasting 7.5 months in one patient out of four patients with chondrosarcoma harboring IDH1 R132C (PMID: 34994649, NCT02576444). 34994649
PALB2 inact mut breast cancer predicted - sensitive Olaparib Phase II Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment resulted in an objective response rate (ORR) of 33% (9/27) and a clinical benefit rate (CBR) at 18 weeks of 50% in patients with metastatic breast cancer harboring germline mutations in homologous recombination-related genes other than BRCA1/2, all responders harbored germline PALB2 inactivating mutations, ORR and CBR in PALB2-mutant patients (n=11) were 82% and 100%, respectively (PMID: 33119476; NCT03344965). 33119476
CDK12 S1236fs triple-receptor negative breast cancer predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment resulted in an unconfirmed partial response with a 33% tumor size reduction in a patient with metastatic triple negative breast cancer harboring a somatic CDK12 S1236fs mutation (PMID: 33119476; NCT03344965). 33119476
PTEN del endometrial carcinoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment did not significantly increase DNA damage or inhibit growth of an endometrial carcinoma cell line with PTEN knocked out via CRISPR/Cas9 system in culture (PMID: 28945226). 28945226
ATM mutant Advanced Solid Tumor conflicting Olaparib Phase II Actionable In a Phase II trial (TAPUR), Lynparza (olaparib) treatment resulted in an objective response rate of 8% and a disease control rate of 25% (9/36, 1 complete response, 2 partial responses, 6 stable disease at 16+ weeks) in patients with advanced solid tumors harboring ATM mutations (Cancer Res 2022;82(12_Suppl):Abstract nr CT110; NCT02693535). detail...
ATM mutant Advanced Solid Tumor conflicting Olaparib Phase II Actionable In a Phase II trial, Lynparza (olaparib) treatment did not demonstrate clinical activity in patients with advanced solid tumors harboring ATM (n=13) or CHEK2 (n=14) mutations (Ann Oncol (2023) 34 (suppl_2): S242; NCT03967938). detail...
DNMT3A del TET2 del acute myeloid leukemia sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) inhibited colony formation of mouse acute myeloid leukemia cells harboring TET2 and DNMT3A deletion along with a FLT3-ITD mutation in culture (PMID: 34215619). 34215619
PALB2 L35P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 L35P were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased cell survival (PMID: 31636395). 31636395
RAD51C T102I Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C T102I sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
TET2 A1505T TET2 mut acute myeloid leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited colony formation of patient-derived acute myeloid leukemia cells harboring FLT3-ITD and a TET2 mutation along with an NPM1 mutation and expressing TET2 A1505T in culture (PMID: 34215619). 34215619
BRIP1 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including BRIP1 (PMID: 32343890; NCT02987543). detail... 32343890 detail...
BRIP1 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in BRIP1 (NCCN.org). detail...
ATM mutant breast cancer no benefit Olaparib Case Reports/Case Series Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment did not result in an objective response in 4 patients with metastatic breast cancer harboring only germline mutations in ATM (PMID: 33119476; NCT03344965). 33119476
RAD51C G130R osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G130R sensitized RAD51C-null osteosarcoma cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell survival (PMID: 37253112). 37253112
RAD51D V200* triple-receptor negative breast cancer sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of triple-negative breast cancer cells expressing RAD51D V200* in culture (PMID: 33151324). 33151324
RAD51C D348V Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C D348V sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C T132R osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C T132R sensitized RAD51C-null osteosarcoma cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell survival (PMID: 37253112). 37253112
PALB2 S172fs Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 S172fs in culture (PMID: 31757951). 31757951
IDH2 mutant acute myeloid leukemia predicted - sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, cells from a patient with acute myeloid leukemia harboring an IDH2 mutation were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
BRIP1 Q554Hfs*35 endometrial serous adenocarcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in rapid clinical improvement and an ongoing complete response 9 months after initiation of treatment in a patient with high-grade serous endometrial carcinoma harboring a BRIP1 Q554Hfs*35 mutation, who also harbored other genomic changes consistent with homologous recombination defects including loss of heterozygosity in BRCA2, MAP3K1, PIK3R1, PTCH1, and KDM6A (PMID: 32923896). 32923896
RAD51D K91fs triple-receptor negative breast cancer sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of triple-negative breast cancer cells expressing RAD51D K91fs in culture (PMID: 33151324). 33151324
RAD51C T336P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C T336P sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C G153D Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G153D sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ARID1A A35Gfs*76 cholangiocarcinoma no benefit Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, a cholangiocarcinoma patient-derived xenograft (PDX) cell line harboring ARID1A A35Gfs*76 was insensitive to Lynparza (olaparib) in culture (PMID: 36374558). 36374558
RAD51C G306R Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G306R sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM V519I neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm V519I, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
CHEK2 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.87 in CHEK2-mutant patients (PMID: 32343890; NCT02987543). detail... detail... 32343890
CHEK2 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in CHEK2 (NCCN.org). detail...
ATM V2288fs prostate cancer predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (TOPARP-A), Lynparza (olaparib) treatment resulted in a conversion in the circulating tumor-cell count, a 29% decrease in PSA level, and radiologic stable disease in a patient with metastatic castration-resistant prostate cancer harboring ATM V2288fs (PMID: 26510020; NCT01682772). 26510020
RAD51C T132P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment resulted in decreased survival of cells expressing RAD51C T132P in culture (PMID: 33832919). 33832919
ATM S824F neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm S824F, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
PALB2 L24F PALB2 Y551* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 L24F sensitized transformed human cells harboring PALB2 Y551* to Lynparza (olaparib) treatment in culture (PMID: 35853885). 35853885
ATM inact mut mantle cell lymphoma sensitive Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, a mantle cell lymphoma cell line with ATM inactivation demonstrated sensitivity to Lynparza (olaparib) in culture and in xenograft models (PMID: 20739657). 20739657
ATM del prostate cancer no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, ATM-deficient prostate cancer cell lines did not respond to treatment with Lynparza (olaparib) in culture (PMID: 32127357). 32127357
RAD51C A155E Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C A155E sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51D S207L Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing RAD51D S207L demonstrated decreased survival when treated with Lynparza (olaparib) in culture (PMID: 28646019). 28646019
ATM del head and neck cancer sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment induced genomic instability, cell cycle arrest, and inhibited viability of an ATM knockout head and neck cancer cell line in culture (PMID: 31699977). 31699977
RAD51C R168G Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C R168G sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
IDH1 R132H high grade glioma predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of a glioma cell line expressing IDH1 R132H in culture (PMID: 34118569). 34118569
IDH1 R132H high grade glioma predicted - sensitive Olaparib Phase II Actionable In a Phase II trial (OLAGLI), Lynparza (olaparib) therapy was well tolerated in high grade glioma patients harboring IDH1 R132 (32/35) or other IDH mutations (3/35), and led to a partial response in 5% (2/35) and stable disease in 37% (14/35) of 35 evaluable patients, median progression-free survival (PFS) of 2.3 mo, median overall survival of 15.9 mo, a median duration of response of 9 mo, and a 6-mo PFS of 31% (11/35) (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 2007-2007; NCT03561870). detail...
RAD51C G125V Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G125V sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD54L inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in RAD54L (NCCN.org). detail...
RAD54L inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.33 in RAD54L-mutant patients (PMID: 32343890; NCT02987543). detail... detail... 32343890
PALB2 inact mut Advanced Solid Tumor sensitive Olaparib Preclinical Actionable In a preclinical study, Lynparza (olaparib) resulted in decreased cell survival in a PALB2 deficient cell line derived from a Fanconi anemia patient (PMID: 20871615). 20871615
ATM A59S neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm A59S, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM K2749I neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm K2749I, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
PALB2 E230* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 E230* in culture (PMID: 31757951). 31757951
IDH1 R132H colorectal cancer predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, colorectal cancer cells harboring IDH1 R132H were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
ATM inact mut prostate cancer sensitive Olaparib Phase II Actionable In a Phase II trial (TOPARP-B), Lynparza (olaparib) treatment resulted in a composite overall response rate of 36.8% (7/19) and a RECIST objective response rate of 8.3% (1/12) in patients with castration-resistant prostate cancer harboring deleterious ATM mutations (PMID: 31806540; NCT01682772). 31806540
ATM inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in ATM (NCCN.org). detail...
ATM inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved progression-free survival (7.4 vs 3.6 mo, HR 0.34, p<0.001), objective response rate (33% vs 2%, OR 20.86, p<0.001), and median overall survival (18.5 vs 15.1 mo, HR 0.64, p=0.02) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious BRCA or ATM mutations, HR for progression or death was 1.04 in ATM-mutant patients (PMID: 32343890; NCT02987543). detail... 32343890 detail...
PALB2 T1030I Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 T1030I were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
PALB2 W1140G osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 W1140G were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
DNMT3A mutant acute myeloid leukemia resistant Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived acute myeloid leukemia cells harboring a DNMT3A mutation along with FLT3-ITD and NPM1 mutation were resistant to Lynparza (olaparib) in culture (PMID: 34215619). 34215619
PALB2 R37H osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 R37H were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
BARD1 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in BARD1 (NCCN.org). detail...
BARD1 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including BARD1 (PMID: 32343890; NCT02987543). detail... 32343890 detail...
IDH1 R132S chondrosarcoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Lynparza (olaparib) treatment resulted in stable disease lasting 10 months in a patient with chondrosarcoma harboring IDH1 R132S (PMID: 34994649, NCT02576444). 34994649
PALB2 Q60Rfs*7 Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 Q60Rfs*7 in culture (PMID: 31757951). 31757951
TET2 mutant acute myeloid leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited colony formation in patient-derived acute myeloid leukemia cells harboring a TET2 mutation along with FLT3-ITD and NPM1 mutation in culture (PMID: 34215619). 34215619
PALB2 inact mut estrogen-receptor positive breast cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy for patients with ESR1 (ER)-positive, ERBB2 (HER2)-negative metastatic breast cancer with germline or somatic pathogenic/likely pathogenic PALB2 mutations who have progressed on an endocrine therapy plus CDK4/6 inhibitor (PMID: 34678411; ESMO.org). detail... 34678411
RAD51C G114V Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G114V sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
IDH1 R132C sarcoma sensitive Olaparib Preclinical - Cell line xenograft Actionable In a preclinical study, Lynparza (olaparib) treatment delayed tumor growth in cell line xenograft models of sarcoma harboring IDH1 R132C (PMID: 28148839). 28148839
PALB2 L947S osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 L947S were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
RAD51C V156D Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C V156D sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM L1956H neuroblastoma no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm L1956H, resulted in similar cell viability levels as cells carrying wild-type Atm (PMID: 29059438). 29059438
DNMT3A loss TET2 loss acute myeloid leukemia sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) inhibited colony formation in murine acute myeloid leukemia cells harboring TET2 and DNMT3A loss along wtih various oncogenic tyrosine kinase mutations in culture (PMID: 34215619). 34215619
ATM inact mut chronic lymphocytic leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived chronic lymphocytic leukemia cells with inactivating mutations in ATM, that had been induced to proliferate in culture, demonstrated increased sensitivity to growth inhibition by Lynparza (olaparib) compared to ATM wild-type cells (PMID: 20739657). 20739657
PALB2 R37H Advanced Solid Tumor conflicting Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 R37H were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
PALB2 R37H Advanced Solid Tumor conflicting Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 R37H did not confer sensitivity to Lynparza (olaparib)-induced growth inhibition in TP53 and PALB2 double knock-out mouse embryonic stem cells in culture (PMID: 33811135). 33811135
PALB2 L35F PALB2 Y551* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 L35F sensitized transformed human cells harboring PALB2 Y551* to Lynparza (olaparib) treatment in culture (PMID: 35853885). 35853885
RAD51D inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51D (PMID: 32343890; NCT02987543). detail... detail... 32343890
RAD51D inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in RAD51D (NCCN.org). detail...
RAD51C H192_R193delinsGG ovarian carcinoma resistant Olaparib Preclinical - Cell culture Actionable In a preclinical study, ovarian carcinoma cells expressing RAD51C H192_R193delinsGG demonstrated resistance to Lynparza (olaparib) in culture (PMID: 28588062). 28588062
ATM H2038Y neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm H2038Y, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM P604S neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm P604S, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
RAD51D loss Advanced Solid Tumor sensitive Olaparib Preclinical Actionable In a preclinical study, cells harboring biallelic loss-of-function mutations in RAD51D had increased sensitivity to Lynparza (olaparib) compared to cells with wild-type RAD51D (PMID: 21822267). 21822267
PALB2 G1043V Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 G1043V conferred sensitivity to Lynparza (olaparib)-induced growth inhibition in TP53 and PALB2 double knock-out mouse embryonic stem cells in culture (PMID: 33811135). 33811135
TP53 mutant ovarian cancer predicted - sensitive Olaparib Preclinical - Pdx Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited tumor growth but did not induce regression in a patient-derived xenograft (PDX) model of ovarian cancer harboring wild-type ATM and TP53 mutation (PMID: 31699977). 31699977
PALB2 K16M PALB2 Y551* Advanced Solid Tumor no benefit Olaparib Preclinical - Cell culture Actionable In a preclinical study, expressing PALB2 K16M did not sensitize transformed human cells harboring PALB2 Y551* to Lynparza (olaparib) treatment in culture (PMID: 35853885). 35853885
PALB2 L1119P osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 L1119P were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
RAD51C K131I osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C K131I sensitized RAD51C-null osteosarcoma cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell survival (PMID: 37253112). 37253112
PALB2 del PALB2 mut prostate cancer predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II study (TOPARP-A), a patient with metastatic castration-resistant prostate cancer harboring a frameshift PALB2 mutation together with a heterozygous PALB2 deletion achieved a response to Lynparza (olaparib) that lasted for 39 weeks (PMID: 26510020; NCT01682772). 26510020
RAD51B inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including RAD51B (PMID: 32343890; NCT02987543). detail... detail... 32343890
RAD51B inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in RAD51B (NCCN.org). detail...
RAD51C D108G Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C D108G sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C K131I Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C K131I sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
TET2 del acute myeloid leukemia sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) inhibited colony formation of mouse acute myeloid leukemia cells harboring TET2 deletion along with a FLT3-ITD mutation in culture (PMID: 34215619). 34215619
ARID1A dec exp breast cancer sensitive Olaparib Preclinical Actionable In a preclinical study, Lynparza (olaparib) inhibited colony formation of human mammary epithelial cells and inhibited proliferation of a human breast cancer cell line after knockdown of ARID1A in culture (PMID: 26069190). 26069190
PALB2 P1009Lfs*6 Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 P1009Lfs*6 in culture (PMID: 31757951). 31757951
PALB2 L1119P Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 L1119P were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
IDH2 V305M malignant epithelioid hemangioendothelioma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (OLAPCO), Lynparza (olaparib) treatment resulted in stable disease lasting 11 months in a patient with pulmonary epithelioid hemangioendothelioma harboring IDH2 V305M (PMID: 34994649, NCT02576444). 34994649
PALB2 Y1183* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 Y1183* in culture (PMID: 31757951). 31757951
ATRX loss IDH1 R132H high grade glioma predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited viability of immortalized astrocytes expressing IDH1 R132H with loss of ATRX in culture (PMID: 34118569). 34118569
PALB2 W1038* Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 W1038* in culture (PMID: 31757951). 31757951
PALB2 L947F osteosarcoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, osteosarcoma cells expressing PALB2 L947F were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
PALB2 Y551* PALB2 S859* Her2-receptor negative breast cancer predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic hormone receptor (ESR1/PGR)-positive, ERBB2 (HER2)-negative breast cancer harboring PALB2 Y551* and S859* who progressed on prior therapies achieved a partial response to Lynparza (olaparib) treatment after 3 months and a 70% decrease in tumor burden at 6 months (PMID: 32194151). 32194151
IDH1 R132H colon carcinoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, colon carcinoma cells over expressing IDH1 R132H demonstrated increased sensitivity to Lynparza (olaparib)-induced growth inhibition in culture (PMID: 28148839). 28148839
BARD1 mutant breast cancer no benefit Olaparib Case Reports/Case Series Actionable In a Phase II trial (TBCRC 048), Lynparza (olaparib) treatment did not result in an objective response in a patient with metastatic breast cancer harboring a germline mutation in BARD1 (PMID: 33119476; NCT03344965). 33119476
RAD51C V140E Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C V140E sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
DNMT3A mut TET2 mut acute myeloid leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment inhibited colony formation in patient-derived acute myeloid leukemia cells co-harboring a DNMT3A and TET2 mutation along with FLT3-ITD and NPM1 mutation in culture (PMID: 34215619). 34215619
RAD51C Q133E Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C Q133E sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
CDK12 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in CDK12 (NCCN.org). detail...
CDK12 inact mut prostate cancer sensitive Olaparib Phase II Actionable In a Phase II trial (TOPARP-B), Lynparza (olaparib) treatment resulted in a composite overall response rate of 25.0% (5/20) and a RECIST objective response rate of 0% (0/18) in patients with castration-resistant prostate cancer harboring deleterious CDK12 mutations (PMID: 31806540; NCT01682772). 31806540
CDK12 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in metastatic castration-resistant prostate cancer patients harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, HR for progression or death was 0.74 in CDK12-mutant patients (PMID: 32343890; NCT02987543). detail... 32343890 detail...
PTEN Y174H PTEN K263* colorectal cancer predicted - sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, Lynparza (olaparib) inhibited cell proliferation in a patient-derived colorectal cancer organoid harboring PTEN Y174H and K263*, along with PIK3CA N1068fs, in culture (PMID: 32376656). 32376656
PALB2 C882fs Advanced Solid Tumor predicted - sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, treatment with Lynparza (olaparib) resulted in decreased survival of TP53-knockout cells expressing PALB2 C882fs in culture (PMID: 31757951). 31757951
PALB2 L947F Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 L947F were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
IDH1 mutant acute myeloid leukemia predicted - sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, cells from a patient with acute myeloid leukemia harboring an IDH1 mutation were sensitive to treatment with Lynparza (olaparib) in culture, demonstrating decreased colony formation (PMID: 29339439). 29339439
BRIP1 T997fs breast lobular carcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in a sustained metabolic response and a decrease in the cancer antigen markers CA 27-29 and CA 15-3 after 8 months in a patient with recurrent ER/PR-positive, ERBB2 (HER2)-negative invasive lobular breast carcinoma harboring a germline BRIP1 T997fs, who remained on treatment (PMID: 36813328). 36813328
RAD51C G150E Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C G150E sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
ATM P960H neuroblastoma sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, Lynparza (olaparib) treatment of neuroblastoma cells in culture, transfected with Atm P960H, resulted in decreased cell viability as compared to cells carrying wild-type Atm (PMID: 29059438). 29059438
ATM inact mut lymphoid leukemia sensitive Olaparib Preclinical - Patient cell culture Actionable In a preclinical study, lymphoblastoid cell lines with ATM inactivation derived from ataxia-telangiectasia patients demonstrated increased sensitivity to Lynparza (olaparib) in culture, compared to ATM wild-type cell lines (PMID: 20739657). 20739657
ATM N2875H prostate cancer predicted - sensitive Olaparib Case Reports/Case Series Actionable In a Phase II trial (TOPARP-A), Lynparza (olaparib) treatment resulted in a conversion in the circulating tumor-cell count and an 85% decrease in PSA level in a patient with metastatic castration-resistant prostate cancer harboring ATM N2875H (PMID: 26510020; NCT01682772). 26510020
PALB2 W1140G Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, cells expressing PALB2 W1140G were sensitive to treatment with Lynparza (olaparib), demonstrating decreased cell growth in culture (PMID: 31586400). 31586400
PALB2 del exon11 endometrial serous adenocarcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in a durable response lasting 23 months in a patient with recurrent serous endometrial carcinoma harboring a germline deletion of PALB2 exon 11 (PMID: 34781271). 34781271
RAD51C mutant ovarian serous carcinoma predicted - sensitive Olaparib Case Reports/Case Series Actionable In a clinical case study, Lynparza (olaparib) treatment resulted in a complete response with treatment ongoing at 14 months in a patient with relapsed, metastatic high grade serous ovarian carcinoma harboring RAD51C mutations (PMID: 36176748). 36176748
CHEK1 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including CHEK1 (PMID: 32343890; NCT02987543). detail... detail... 32343890
CHEK1 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in CHEK1 (NCCN.org). detail...
CHEK2 mutant Advanced Solid Tumor no benefit Olaparib Phase II Actionable In a Phase II trial, Lynparza (olaparib) treatment did not demonstrate clinical activity in patients with advanced solid tumors harboring ATM (n=13) or CHEK2 (n=14) mutations (Ann Oncol (2023) 34 (suppl_2): S242; NCT03967938). detail...
RAD51C R312W Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C R312W sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
RAD51C S163R Advanced Solid Tumor sensitive Olaparib Preclinical - Cell culture Actionable In a preclinical study, the expression of RAD51C S163R sensitized RAD51C-deficient cells to Lynparza (olaparib) treatment in culture, resulting in decreased cell proliferation (PMID: 37253112). 37253112
PALB2 inact mut prostate cancer sensitive Olaparib Phase II Actionable In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 57.1% (4/7) and a RECIST objective response rate of 33.3% (2/6) in patients with castration-resistant prostate cancer harboring deleterious PALB2 mutations (PMID: 31806540; NCT01682772). 31806540
PALB2 inact mut prostate cancer sensitive Olaparib Guideline Actionable Lynparza (olaparib) is included in guidelines as second-line therapy post androgen receptor-directed therapy for patients with metastatic castration-resistant prostate cancer harboring pathogenic mutations in PALB2 (NCCN.org). detail...
PALB2 inact mut prostate cancer sensitive Olaparib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROfound) that supported FDA approval, Lynparza (olaparib) treatment significantly improved median imaging-based progression-free survival (5.8 vs 3.5 mo, HR 0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer who progressed on hormone therapy and harbored deleterious or suspected deleterious mutations in homologous recombination repair genes, including PALB2 (PMID: 32343890; NCT02987543). detail... detail... 32343890

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04456699 Phase III Bevacizumab + Olaparib Bevacizumab + Fluorouracil Olaparib Efficacy and Safety of Olaparib, Olaparib + Bevacizumab Compared to Bevacizumab + 5-Fluorouracil (FU) Completed USA | FRA | ESP | DEU | CAN | BEL | AUS 11
NCT02983799 Phase II Olaparib Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status Completed USA | CAN 0
NCT02502266 Phase II Topotecan Paclitaxel Doxorubicin Olaparib Cediranib Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Active, not recruiting USA | CAN 3
NCT04042831 Phase II Olaparib Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations Recruiting USA 0
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Recruiting USA 0
NCT04644289 Phase II Olaparib Durvalumab + Olaparib WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC (WoO) Recruiting DEU 0
NCT03660826 Phase II Olaparib Cediranib + Olaparib Olaparib and Cediranib Maleate in Treating Patients With Recurrent, Refractory, or Metastatic Endometrial Cancer Active, not recruiting USA | CAN 0
NCT04041128 Phase I Olaparib PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer Completed USA 0
NCT04550104 Phase I AZD1390 Olaparib A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC (CONCORDE) Recruiting GBR 0
NCT03432897 Phase II Olaparib BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes (337) Terminated USA 0
NCT03167619 Phase II Durvalumab + Olaparib Olaparib Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (DORA) Completed USA 0
NCT04858334 Phase II Olaparib APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation Recruiting USA 0
NCT03286842 Phase III Olaparib To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients. Completed USA | ITA | GBR | FRA | ESP | DEU | CAN 8
NCT03263650 Phase II Cabazitaxel + Carboplatin Olaparib Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC Active, not recruiting USA 0
NCT03955640 Phase I Olaparib Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences Unknown status USA 0
NCT03106987 Phase III Olaparib A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer. (OReO) Completed ITA | GBR | FRA | ESP | DEU | CAN | BEL 4
NCT06120972 Phase II Olaparib Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency Recruiting USA 0
NCT03344965 Phase II Olaparib Olaparib In Metastatic Breast Cancer Active, not recruiting USA 0
NCT04348045 Phase II Durvalumab + Selumetinib Fluorouracil + Irinotecan + Leucovorin Olaparib Personalized Maintenance Therapy for m-PDAC Using Olaparib or Selumetinib + Durvalumab, Based on BRCAness and KRAS Status. (MAZEPPA) Active, not recruiting FRA 0
NCT04038502 Phase II Olaparib Carboplatin Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA) Recruiting USA 0
NCT02693535 Phase II Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) Recruiting USA 0
NCT02893917 Phase II Cediranib + Olaparib Olaparib Olaparib With or Without Cediranib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Active, not recruiting USA 0
NCT03579316 Phase II Olaparib Adavosertib + Olaparib Adavosertib With or Without Olaparib in Treating Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Recruiting USA 0
NCT02446704 Phase Ib/II Olaparib Temozolomide Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy Unknown status USA 0
NCT03532880 Phase I Olaparib A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer Active, not recruiting USA 0
NCT03205761 Phase II Olaparib Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer (COMETABreast) Completed ESP 0
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting CAN 0
NCT03967938 Phase II Olaparib Efficacy of Olaparib in Advanced Cancers Occurring in Patients With Germline Mutations or Somatic Tumor Mutations in Homologous Recombination Genes (1-2018 BSMO) Recruiting BEL 0
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Withdrawn 0
NCT03079687 Expanded access Olaparib Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer. Approved for marketing USA 0
NCT02282020 Phase III Topotecan Paclitaxel Pegylated liposomal doxorubicin Gemcitabine Olaparib Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments (SOLO3) Completed USA | ITA | ESP | CAN | BEL 8
NCT02032823 Phase III Olaparib Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 13
NCT02184195 Phase III Olaparib Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 2
NCT05564377 Phase II Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Recruiting USA 1
NCT05501548 Phase II Olaparib Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer Recruiting USA 0
NCT04377087 Phase II Olaparib Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer Terminated USA 0
NCT02446600 Phase III Cediranib + Olaparib Olaparib Carboplatin + Gemcitabine + Paclitaxel + Pegylated liposomal doxorubicin Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Active, not recruiting USA | CAN 2
NCT03598257 Phase II Olaparib Radiation Therapy With or Without Olaparib in Treating Participants With Inflammatory Breast Cancer Recruiting USA | CAN 1
NCT05898399 Phase Ib/II Olaparib ART6043 Talazoparib ART6043 + Olaparib ART6043 + Talazoparib Study of ART6043 in Advanced/Metastatic Solid Tumors Patients Recruiting USA 0
NCT03943173 Phase I Olaparib Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery Active, not recruiting USA 0
NCT02576444 Phase II Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib OLAParib COmbinations (OLAPCO) Terminated USA 0
NCT05332561 Phase II Olaparib Ipatasertib Sacituzumab govitecan-hziy Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) Recruiting DEU 0
NCT03330847 Phase II Adavosertib + Olaparib Olaparib Ceralasertib + Olaparib To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL 6
NCT02849496 Phase II Olaparib Atezolizumab + Olaparib Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer Active, not recruiting USA 0
NCT02000622 Phase III Olaparib Vinorelbine Eribulin Capecitabine Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD) Active, not recruiting USA | ITA | GBR | FRA | ESP 14
NCT02511795 Phase I Adavosertib Olaparib AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors Completed USA | CAN 0
NCT05340413 Phase II Olaparib Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. (RADIOLA) Recruiting ESP 0
NCT03317392 Phase Ib/II Olaparib Olaparib and Radium Ra 223 Dichloride in Treating Men With Metastatic Castration-Resistant Prostate Cancer That Has Spread to the Bone Suspended USA 0
NCT05255653 Phase II Olaparib Medroxyprogesterone Carboplatin Megestrol acetate Paclitaxel Cisplatin Durvalumab Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) Recruiting NLD | GBR | FRA | CAN 0
NCT05482074 Phase II Olaparib Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 Withdrawn 0
NCT03259503 Phase Ib/II Busulfan Olaparib Vorinostat Palifermin Gemcitabine Melphalan Dexamethasone Pyridoxine Rituximab Olaparib Combined With High-Dose Chemotherapy for Refractory Lymphomas Active, not recruiting USA 0
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting USA | CAN | AUS 1
NCT02485990 Phase Ib/II Olaparib Tremelimumab Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma) Terminated USA 0
NCT02489006 Phase II Olaparib A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Active, not recruiting NZL | GBR | ESP | CAN 0
NCT03402841 Phase III Olaparib Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (OPINION) Completed NLD | ITA | GBR | ESP | CAN | BEL | AUT 11
NCT03742895 Phase II Olaparib Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) Recruiting USA | ITA | GBR | FRA | ESP | CAN | AUS 14
NCT03367689 Phase II Olaparib A Two-stage Simon Design Phase II Study for Non-BRCA MBC Patients With HRD Treated With Olaparib Single Agent (NOBROLA) Terminated ESP 0
NCT04034927 Phase II Olaparib Olaparib + Tremelimumab Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer Active, not recruiting USA 0
NCT04236414 Phase I Olaparib Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 8
NCT04239014 Phase II Olaparib Ceralasertib + Olaparib A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment. (DUETTE) Withdrawn USA | ITA | ESP | CAN 0
NCT02392676 Phase III Olaparib Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations Withdrawn USA | GBR 3
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Terminated USA 0
NCT02029001 Phase II Durvalumab + Tremelimumab Olaparib Pazopanib Nilotinib Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment (MOST plus) Recruiting FRA 0
NCT03448718 Phase II Olaparib Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations Completed USA 0
NCT03740893 Phase II Olaparib Ceralasertib Durvalumab PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer (PHOENIX) Recruiting GBR 0
NCT03022409 Phase I Olaparib Ceralasertib A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Completed USA | FRA 1
NCT05233982 Phase II Olaparib MITO 35a: Olaparib Maintenance Therapy in Newly Diagnosed BRCA Wild-type Advanced Ovarian, Fallopian Tube and Primitive Peritoneal Cancer (MITO 35a) Recruiting ITA 0
NCT02787642 Phase I Olaparib A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma (RADIOSARP) Completed FRA 0
NCT04548752 Phase II Olaparib + Pembrolizumab Olaparib Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations Recruiting USA 0
NCT04515836 Phase II Olaparib Olaparib in Patients With HRD Malignant Mesothelioma Recruiting USA 0
NCT04421963 Phase III Olaparib Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (ROSY-O) Enrolling by invitation USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 16
NCT03212274 Phase II Olaparib Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Active, not recruiting USA 0
NCT02987543 Phase III Olaparib Enzalutamide Abiraterone Study of Olaparib (Lynparza) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 10
NCT03682289 Phase II Ceralasertib + Olaparib Olaparib Phase II Trial of AZD6738 Alone and in Combination With Olaparib Recruiting USA 0
NCT02925234 Phase II Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab The Drug Rediscovery Protocol (DRUP Trial) (DRUP) Recruiting NLD 0
NCT01972217 Phase II Prednisone Abiraterone Olaparib Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer Completed USA | NLD | ITA | GBR | FRA | ESP | CAN | BEL 3
NCT06245889 Phase II Cyclophosphamide Olaparib Carboplatin + Paclitaxel + Pembrolizumab Doxorubicin Capecitabine PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC (NeoADAPT) Recruiting USA 0
NCT03531840 Phase II Olaparib Olaparib in People With Malignant Mesothelioma Completed USA 0
NCT03745950 Phase II Olaparib UTOLA: UTerin OLAparib (UTOLA) Active, not recruiting FRA 0
NCT05498155 Phase II Olaparib Durvalumab + Olaparib Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (OlympiaN) Active, not recruiting USA | ITA | GBR | ESP | DEU | BEL | AUT | AUS 1
NCT02561832 Phase I Cyclophosphamide Olaparib Carboplatin A Study to Assess the Safety, Tolerability and Efficacy of Olaparib in Combination With Carboplatin in Patients With HER-2 Negative Breast Cancer Terminated USA | ESP 0
NCT05432518 Phase I Olaparib Palbociclib Afatinib Everolimus Dasatinib GBM Personalized Trial Recruiting CAN 0
NCT05255471 Phase III Carboplatin + Paclitaxel Olaparib Carboplatin + Pegylated liposomal doxorubicin Carboplatin + Gemcitabine MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. (MITO 35B) Recruiting ITA 0
NCT04951492 Phase II Olaparib Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma Terminated USA 0
NCT03737643 Phase III Bevacizumab + Carboplatin + Paclitaxel Bevacizumab + Carboplatin + Durvalumab + Paclitaxel Bevacizumab + Durvalumab + Olaparib Olaparib Bevacizumab + Durvalumab Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients. (DUO-O) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT04091204 Phase II Olaparib Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study (MITO 31) Recruiting ITA 0
NCT03375307 Phase II Olaparib Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes Recruiting USA 0
NCT05078671 FDA approved Olaparib Cobicistat + Olaparib Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness (PROACTIVE) Recruiting NLD 0
NCT03741426 Phase II Durvalumab Cediranib Durvalumab + Olaparib Cediranib + Olaparib Olaparib WIRE - Novel Treatments in Renal Cell Cancer (WIRE) Recruiting GBR 0
NCT03953898 Phase II Olaparib Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation Active, not recruiting USA 0
NCT01844986 Phase III Olaparib Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | CAN | AUS 7
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Active, not recruiting USA 0
NCT03278717 Phase III Olaparib Cediranib + Olaparib Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients (ICON9) Recruiting NZL | GBR | CAN | AUS 0
NCT01874353 Phase III Olaparib Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 7
NCT03012321 Phase II Abiraterone + Olaparib + Prednisone Abiraterone + Prednisone Olaparib Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects Active, not recruiting USA 0
NCT05949424 FDA approved Lenvatinib Olaparib Pazopanib Palbociclib Sunitinib OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults (OPTI-DOSE) Not yet recruiting NLD 0
NCT04614909 Phase I Olaparib Pamiparib Pamiparib + Temozolomide Olaparib + Pamiparib + Temozolomide Phase 0/2 Study of Pamiparib in Newly Diagnosed and rGBM Recruiting USA 0
NCT01116648 Phase Ib/II Olaparib Cediranib + Olaparib Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer Active, not recruiting USA 0
NCT02588105 Phase I Olaparib AZD0156 Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer Completed USA | GBR | ESP 1
NCT04005690 Phase II Olaparib Cobimetinib Cobimetinib or Olaparib in Treating Patients With Resectable Pancreatic Cancer Recruiting USA 0
NCT01445418 Phase I Olaparib Carboplatin AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer Completed USA 0
NCT02677038 Phase II Olaparib Olaparib in Treating Patients With Stage IV Pancreatic Cancer Completed USA 0
NCT06078787 Phase II Olaparib Olaparib in PALB2 Advanced Pancreatic Cancer (PALBOLA) Recruiting ITA 0
NCT05286827 Phase II Olaparib Phase II Study of Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma Recruiting USA 0
NCT03233204 Phase II Olaparib Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Active, not recruiting USA 1
NCT02476968 FDA approved Olaparib To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (ORZORA) Completed ITA | GBR | ESP | CAN 4
NCT03570476 Phase II Olaparib Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer Terminated USA 0
NCT03498521 Phase II Atezolizumab + Paclitaxel Carboplatin Carboplatin + Paclitaxel Olaparib Vismodegib Alectinib Bevacizumab + Erlotinib Cisplatin + Gemcitabine Cobimetinib + Vemurafenib Ipatasertib + Paclitaxel Cisplatin + Paclitaxel Gemcitabine Atezolizumab Entrectinib Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Ipatasertib Carboplatin + Gemcitabine A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (CUPISCO) Active, not recruiting NLD | ITA | GBR | FRA | ESP | DEU | AUT | AUS 25


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