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 use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, germline BRCA-mutated and ERBB2 (HER2)-negative breast cancer, and advanced epithelial ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline or somatic BRCA mutations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Olaparib | Lynparza | AZD2281|KU-0059436 | PARP Inhibitor (Pan) 22 | 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 with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations who progressed following enzalutamide or abiraterone, 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring BRIP1 mutations (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 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 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 |
| CHEK1 inact mut | prostate cancer | sensitive | Olaparib | Case Reports/Case Series | Actionable | In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 20.0% (4/20) and a RECIST objective response rate of 0% (0/17) in patients with castration-resistant prostate cancer harboring deleterious mutations in DNA damage response genes, including ARID1A, ATRX, CHEK1/2, FANCA, FANCF, FANCG, FANCI, FANCM, MSH2, NBN, RAD50, and WRN (n=1, 1, 1, 5, 5, 2, 1, 1, 2, 1, 1, 1, 7, respectively) (PMID: 31806540; NCT01682772). | 31806540 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring CHEK1 mutations (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... |
| 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 |
| Unknown unknown | ovarian cancer | not applicable | Olaparib | FDA approved | Actionable | In a Phase II trial that supported FDA approval, Lynparza (olaparib) maintenance therapy resulted in significantly improved progression-free survival compared to placebo (8.4 vs 4.8 mo, HR=0.35, p<0.001) in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneum cancer (PMID: 22452356; NCT00753545). | 22452356 detail... |
| 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 |
| 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 |
| Unknown unknown | malignant astrocytoma | not applicable | Olaparib | Preclinical - Cell culture | Actionable | In a preclinical study, Lynparza (olaparib) resulted in decreased cell viability of some pediatric high grade astrocytoma cell lines in culture (PMID: 26351319). | 26351319 |
| 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 |
| 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 |
| 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 |
| Unknown unknown | prostate cancer | not applicable | Olaparib | Phase II | Actionable | In a Phase II clinical trial, 86.7% (13/15) of metastatic castration-resistant prostate cancer patients with mutations in DNA repair genes demonstrated response to Lynparza (olaparib) treatment (Cancer Res August 1, 2015 75:CT322). | detail... |
| CHEK2 inact mut | prostate cancer | sensitive | Olaparib | Case Reports/Case Series | Actionable | In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 20.0% (4/20) and a RECIST objective response rate of 0% (0/17) in patients with castration-resistant prostate cancer harboring deleterious mutations in DNA damage response genes, including ARID1A, ATRX, CHEK1/2, FANCA, FANCF, FANCG, FANCI, FANCM, MSH2, NBN, RAD50, and WRN (n=1, 1, 1, 5, 5, 2, 1, 1, 2, 1, 1, 1, 7, respectively) (PMID: 31806540; NCT01682772). | 31806540 |
| 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) treatment significantly improved progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring CHEK2 mutations (5.59 vs 3.35 mo) (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... |
| Unknown unknown | brain stem glioma | not applicable | Olaparib | Preclinical - Cell culture | Actionable | In a preclinical study, Lynparza (olaparib) resulted in decreased cell viability of some diffuse intrinsic pontine glioma cell lines in culture (PMID: 26351319). | 26351319 |
| 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 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring RAD51C mutations (PMID: 32343890; NCT02987543). | detail... detail... 32343890 |
| 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 |
| 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 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 |
| Unknown unknown | head and neck cancer | not applicable | Olaparib | Preclinical - Pdx | Actionable | In a preclinical study, a patient-dervived xenograft (PDX) model of head and neck cancer harboring mutant TP53 and wild-type ATM did not demonstrate sensitivity to Lynparza (olaparib) treatment (PMID: 31699977). | 31699977 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring RAD51B mutations (10.89 vs 1.77 mo) (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... |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| PALB2 mutant | prostate cancer | sensitive | Olaparib | Case Reports/Case Series | Actionable | In a Phase II study, a patient with metastatic castration-resistant prostate cancer harboring PALB2 mutation had a response to Lynparza (olaparib), which lasted for 39 weeks (PMID: 26510020). | 26510020 |
| 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 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 |
| 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 |
| 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) treatment significantly improved progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring RAD54L mutations (7.20 vs 2.41 mo) (PMID: 32343890; NCT02987543). | detail... detail... 32343890 |
| 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 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring BARD1 mutations (PMID: 32343890; NCT02987543). | detail... 32343890 detail... |
| 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... |
| 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 |
| FANCA inact mut | prostate cancer | predicted - sensitive | Olaparib | Case Reports/Case Series | Actionable | In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 20.0% (4/20) and a RECIST objective response rate of 0% (0/17) in patients with castration-resistant prostate cancer harboring deleterious mutations in DNA damage response genes, including ARID1A, ATRX, CHEK1/2, FANCA, FANCF, FANCG, FANCI, FANCM, MSH2, NBN, RAD50, and WRN (n=1, 1, 1, 5, 5, 2, 1, 1, 2, 1, 1, 1, 7, respectively) (PMID: 31806540; NCT01682772). | 31806540 |
| 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 |
| 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 mutant | 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 mutations, ORR and CBR in PALB2-mutant patients (n=11) were 82% and 100%, respectively (PMID: 33119476; NCT03344965). | 33119476 |
| 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 |
| 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 |
| Unknown unknown | colorectal cancer | no benefit | Olaparib | Phase II | Actionable | In a Phase II clinical trial, treatment with Lynparza (olaparib) did not result in clinical activity in colorectal cancer patients that had progressed on prior standard therapy, including both microsatellite-stable patients and those that demonstrated high microsatellite instability (PMID: 26786262). | 26786262 |
| 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 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 |
| 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 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 |
| ARID1A inact mut | prostate cancer | predicted - sensitive | Olaparib | Case Reports/Case Series | Actionable | In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 20.0% (4/20) and a RECIST objective response rate of 0% (0/17) in patients with castration-resistant prostate cancer harboring deleterious mutations in DNA damage response genes, including ARID1A, ATRX, CHEK1/2, FANCA, FANCF, FANCG, FANCI, FANCM, MSH2, NBN, RAD50, and WRN (n=1, 1, 1, 5, 5, 2, 1, 1, 2, 1, 1, 1, 7, respectively) (PMID: 31806540; NCT01682772). | 31806540 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 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 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 |
| 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 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 |
| 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 | 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 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 | Phase II | Actionable | In a Phase II clinical trial, 80% (4/5) of metastatic, castration-resistant prostate cancer patients harboring an ATM inactivating mutation responded to Lynparza (olaparib) (PMID: 26510020). | 26510020 |
| 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) treatment improved progression-free survival (7.4 vs 3.6 mo, HR=0.34, p<0.001), objective response rate (33%, 28/84 vs 2%, 1/43, OR=20.86, p<0.001), and median time to pain progression (HR=0.44, p=0.02) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in BRCA1/2 or ATM who progressed on hormone therapy (PMID: 32343890; NCT02987543). | detail... 32343890 detail... |
| 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 |
| 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 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 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 |
| 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... |
| 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 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring RAD51D mutations (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... |
| 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 (TOPARP-B) trial, 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) treatment significantly improved progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring CDK12 mutations (5.09 vs 2.20 mo) (PMID: 32343890; NCT02987543). | detail... 32343890 detail... |
| 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 |
| 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 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 |
| 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 |
| 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 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 |
| ATRX inact mut | prostate cancer | predicted - sensitive | Olaparib | Case Reports/Case Series | Actionable | In a Phase II (TOPARP-B) trial, Lynparza (olaparib) treatment resulted in a composite overall response rate of 20.0% (4/20) and a RECIST objective response rate of 0% (0/17) in patients with castration-resistant prostate cancer harboring deleterious mutations in DNA damage response genes, including ARID1A, ATRX, CHEK1/2, FANCA, FANCF, FANCG, FANCI, FANCM, MSH2, NBN, RAD50, and WRN (n=1, 1, 1, 5, 5, 2, 1, 1, 2, 1, 1, 1, 7, respectively) (PMID: 31806540; NCT01682772). | 31806540 |
| 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 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring PALB2 mutations (PMID: 32343890; NCT02987543). | detail... detail... 32343890 |
| 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 progression-free survival (PFS, 5.8 vs 3.5 mo, HR=0.49, p<0.001) compared to control in patients with metastatic castration-resistant prostate cancer harboring deleterious or suspected deleterious mutations in homologous recombination repair genes who progressed on hormone therapy, including patients harboring FANCL mutations (PMID: 32343890; NCT02987543). | detail... detail... 32343890 |
| 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 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | 1 |
| 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 | Suspended | USA | 0 |
| NCT03106987 | Phase III | Olaparib | A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer. (OReO) | Active, not recruiting | CAN | 10 |
| NCT04239014 | Phase II | Olaparib AZD6738 + 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 | CAN | 2 |
| 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 |
| 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 | Recruiting | USA | 0 |
| 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 | 1 |
| NCT02849496 | Phase II | Olaparib Atezolizumab + Olaparib | Olaparib With or Without Atezolizumab in Treating Patients With Locally Advanced Unresectable or Metastatic Non-HER2-Positive Breast Cancer | Recruiting | USA | 0 |
| NCT04515836 | Phase II | Olaparib | Olaparib in Patients With HRD Malignant Mesothelioma | Not yet 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 | 18 |
| 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 |
| NCT02677038 | Phase II | Olaparib | Olaparib in Treating Patients With Stage IV Pancreatic Cancer | Active, not recruiting | USA | 0 |
| NCT02693535 | Phase II | Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab 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 | Recruiting | USA | 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) | Recruiting | USA | 0 |
| NCT01445418 | Phase I | Olaparib Carboplatin | AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer | Completed | USA | 0 |
| NCT03212274 | Phase II | Olaparib | Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations | Recruiting | USA | 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 | Recruiting | USA | 0 |
| NCT03402841 | Phase III | Olaparib | Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (OPINION) | Active, not recruiting | CAN | 17 |
| 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) | Recruiting | USA | 1 |
| 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 |
| NCT03286842 | Phase III | Olaparib | To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients. | Active, not recruiting | USA | CAN | 13 |
| NCT03344965 | Phase II | Olaparib | Olaparib In Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT02983799 | Phase II | Olaparib | Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status | Completed | USA | CAN | 0 |
| NCT03955640 | Phase I | Olaparib | Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences | Recruiting | USA | 0 |
| NCT02476968 | FDA approved | Olaparib | To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (ORZORA) | Active, not recruiting | CAN | 7 |
| NCT04041128 | Phase I | Olaparib | PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer | Recruiting | USA | 0 |
| 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 | CAN | 19 |
| NCT03943173 | Phase I | Olaparib | Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery | Recruiting | USA | 0 |
| NCT03531840 | Phase II | Olaparib | Olaparib in People With Malignant Mesothelioma | Completed | USA | 0 |
| NCT03448718 | Phase II | Olaparib | Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations | Recruiting | USA | 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 |
| NCT03022409 | Phase I | Olaparib AZD6738 | 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 | 3 |
| 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 |
| NCT02787642 | Phase I | Olaparib | A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma (RADIOSARP) | Recruiting | 1 | |
| 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) | Active, not recruiting | USA | CAN | 11 |
| 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 | Recruiting | USA | 0 |
| NCT02489006 | Phase II | Olaparib | A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer | Recruiting | CAN | 3 |
| NCT03047135 | Phase II | Olaparib | Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis | Recruiting | USA | 0 |
| NCT02029001 | Phase II | Durvalumab + Tremelimumab Olaparib Pazopanib Nilotinib | Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: My Own Specific Treatment (MOST plus) | Recruiting | 1 | |
| NCT03167619 | Phase II | Durvalumab + Olaparib Olaparib | Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (DORA) | Active, not recruiting | USA | 0 |
| NCT04421963 | Phase III | Olaparib | Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (ROSY-O) | Recruiting | USA | CAN | 7 |
| NCT03259503 | Phase Ib/II | Busulfan Olaparib Vorinostat Palifermin Gemcitabine Melphalan Dexamethasone Pyridoxine Rituximab | Olaparib Combined With High-Dose Chemotherapy for Refractory Lymphomas | Recruiting | USA | 0 |
| NCT02446600 | Phase III | Cediranib + Olaparib Olaparib Carboplatin + Gemcitabine + Paclitaxel + Pegylated liposomal-doxorubicin | Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Active, not recruiting | USA | CAN | 2 |
| NCT03375307 | Phase II | Olaparib | Olaparib in Treating Patients With Metastatic or Advanced Urothelial Cancer With DNA-Repair Defects | Recruiting | USA | 0 |
| NCT04456699 | Phase III | Bevacizumab + Olaparib Bevacizumab + Fluorouracil Olaparib | Efficacy and Safety of Olaparib, Olaparib + Bevacizumab Compared to Bevacizumab + 5-Fluorouracil (FU) | Recruiting | USA | CAN | 14 |
| NCT03330847 | Phase II | Adavosertib + Olaparib Olaparib AZD6738 + Olaparib | To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy. | Active, not recruiting | USA | CAN | 13 |
| NCT04377087 | Phase II | Olaparib | Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer | Recruiting | USA | 0 |
| NCT02576444 | Phase II | Adavosertib + Olaparib Olaparib Capivasertib + Olaparib AZD6738 + Olaparib | OLAParib COmbinations (OLAPCO) | 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) | Active, not recruiting | USA | CAN | 19 |
| 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 |
| 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) | Recruiting | 35 | |
| NCT02511795 | Phase I | Adavosertib Olaparib | AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors | Completed | USA | CAN | 0 |
| NCT03532880 | Phase I | Olaparib | A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer | Recruiting | USA | 0 |
| NCT04042831 | Phase II | Olaparib | Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations | Recruiting | USA | 0 |
| NCT03660826 | Phase II | Olaparib Cediranib + Olaparib | Olaparib and Cediranib Maleate in Treating Patients With Recurrent, Refractory, or Metastatic Endometrial Cancer | Suspended | USA | 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 | CAN | 15 |
| 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) | 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 | Active, not recruiting | 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) | Recruiting | USA | CAN | 18 |
| NCT04038502 | Phase II | Olaparib Carboplatin | Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA) | Recruiting | USA | 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 | Recruiting | USA | CAN | 3 |
| 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 | CAN | 22 |
| 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 | Active, not recruiting | USA | 3 |
| NCT02184195 | Phase III | Olaparib | Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO) | Active, not recruiting | USA | CAN | 10 |
| 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 | CAN | 13 |
| 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 |
| 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 |
| NCT03598257 | Phase II | Olaparib | Radiation Therapy With or Without Olaparib in Treating Participants With Inflammatory Breast Cancer | Recruiting | USA | CAN | 1 |
| NCT03682289 | Phase II | AZD6738 + Olaparib Olaparib | Phase II Trial of AZD6738 Alone and in Combination With Olaparib | Recruiting | USA | 0 |
| NCT01972217 | Phase II | Prednisone Abiraterone Olaparib | Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer | Active, not recruiting | USA | CAN | 9 |
| NCT04005690 | Phase II | Olaparib Cobimetinib | Cobimetinib or Olaparib in Treating Patients With Resectable Pancreatic Cancer | Recruiting | USA | 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 | 4 |
| NCT03786796 | Phase II | Olaparib | Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) | 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 |
| NCT03570476 | Phase II | Olaparib | Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer | Terminated | USA | 0 |
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