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) 29 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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... |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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... |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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... |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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... |
| 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 |
| 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 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 |
| 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 |
| 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 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 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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... |
| 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... |
| 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 |
| 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 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 |
| ARID1B Q127_Q131del IDH1 R132L | cholangiocarcinoma | no benefit | Olaparib | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, a cholangiocarcinoma patient-derived xenograft (PDX) cell line harboring IDH1 R132L and ARID1B Q127_Q131del was insensitive to Lynparza (olaparib) in culture and did not inhibit tumor growth in the patient-derived xenograft model (PMID: 36374558). | 36374558 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 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 |
| 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 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 |
| 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 |
| 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... |
| 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... |
| 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 |
| 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... |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04038502 | Phase II | Olaparib Carboplatin | Carboplatin or Olaparib for BRcA Deficient Prostate Cancer (COBRA) | Recruiting | USA | 0 |
| NCT03745950 | Phase II | Olaparib | UTOLA: UTerin OLAparib (UTOLA) | Active, not recruiting | FRA | 0 |
| NCT04515836 | Phase II | Olaparib | Olaparib in Patients With HRD Malignant Mesothelioma | Recruiting | USA | 0 |
| NCT03448718 | Phase II | Olaparib | Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations | Completed | USA | 0 |
| 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) | 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 | ITA | GBR | FRA | ESP | CAN | AUS | 8 |
| 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 |
| NCT05898399 | Phase Ib/II | Olaparib ART6043 Talazoparib ART6043 + Olaparib ART6043 + Talazoparib | Study of ART6043 in Advanced/Metastatic Solid Tumors Patients | Recruiting | USA | 0 |
| NCT03402841 | Phase III | Olaparib | Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (OPINION) | Completed | ITA | GBR | ESP | CAN | BEL | AUT | 12 |
| 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 |
| 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 |
| 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 |
| NCT03344965 | Phase II | Olaparib | Olaparib In Metastatic Breast Cancer | Recruiting | USA | 0 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
| NCT02787642 | Phase I | Olaparib | A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma (RADIOSARP) | Completed | FRA | 0 |
| NCT05482074 | Phase II | Olaparib | Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 | Recruiting | USA | 0 |
| NCT04951492 | Phase II | Olaparib | Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma | Recruiting | USA | 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 | Not yet recruiting | USA | 0 |
| NCT03741426 | Phase II | Durvalumab Cediranib Durvalumab + Olaparib Cediranib + Olaparib Olaparib | WIRE - Novel Treatments in Renal Cell Cancer (WIRE) | Recruiting | GBR | 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 |
| 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 |
| 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 | ITA | GBR | FRA | ESP | DEU | AUT | AUS | 26 |
| NCT05340413 | Phase II | Olaparib | Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. (RADIOLA) | Recruiting | ESP | 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 |
| 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 |
| 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 | Recruiting | USA | 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 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | 7 |
| 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 |
| 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 |
| 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 |
| NCT04348045 | Phase II | Durvalumab + Selumetinib Fluorouracil + Irinotecan + Leucovorin Olaparib | Phase II Study to Evaluate MAintenance Therapy With Olaparib or Selumetinib Plus Durvalumab According to BRCAness and KRAS Somatic Status Personalized in Metastatic Pancreatic Adenocarcinoma Patients (D19-02) | Recruiting | FRA | 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 |
| NCT05432518 | Phase I | Olaparib Palbociclib Afatinib Everolimus Dasatinib | GBM Personalized Trial | Recruiting | CAN | 0 |
| 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 |
| 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 |
| 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 |
| NCT04042831 | Phase II | Olaparib | Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations | Recruiting | USA | 0 |
| NCT02576444 | Phase II | Adavosertib + Olaparib Olaparib Capivasertib + Olaparib Ceralasertib + Olaparib | OLAParib COmbinations (OLAPCO) | Terminated | USA | 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 |
| 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 |
| 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 |
| NCT01972217 | Phase II | Prednisone Abiraterone Olaparib | Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer | Completed | USA | ITA | GBR | FRA | ESP | CAN | BEL | 4 |
| NCT03955640 | Phase I | Olaparib | Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences | Unknown status | USA | 0 |
| NCT04550104 | Phase I | AZD1390 Olaparib | A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC (CONCORDE) | Recruiting | GBR | 0 |
| NCT02184195 | Phase III | Olaparib | Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO) | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 3 |
| NCT04377087 | Phase II | Olaparib | Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer | Terminated | USA | 0 |
| NCT01445418 | Phase I | Olaparib Carboplatin | AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer | Completed | 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 | Active, not recruiting | USA | CAN | 3 |
| 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 |
| NCT04005690 | Phase II | Olaparib Cobimetinib | Cobimetinib or Olaparib in Treating Patients With Resectable Pancreatic Cancer | 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 |
| NCT05286827 | Phase II | Olaparib | Phase II Study of Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma | Recruiting | USA | 0 |
| NCT02511795 | Phase I | Adavosertib Olaparib | AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors | Completed | USA | CAN | 0 |
| 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 |
| 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 |
| 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 |
| NCT03278717 | Phase III | Olaparib Cediranib + Olaparib | Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients (ICON9) | Recruiting | GBR | CAN | AUS | 1 |
| NCT06078787 | Phase II | Olaparib | Olaparib in PALB2 Advanced Pancreatic Cancer (PALBOLA) | Recruiting | ITA | 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 |
| 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 |
| NCT06120972 | Phase II | Olaparib | Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency | Not yet recruiting | 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 8 |
| 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 |
| 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 |
| NCT05255653 | Phase II | Olaparib Medroxyprogesterone Carboplatin Megestrol acetate Paclitaxel Cisplatin Durvalumab | Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) | Recruiting | GBR | FRA | CAN | 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 |
| 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 |
| NCT03532880 | Phase I | Olaparib | A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung 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 |
| NCT03786796 | Phase II | Olaparib | Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) | Recruiting | 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 | GBR | ESP | CAN | 1 |
| NCT04041128 | Phase I | Olaparib | PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer | Completed | USA | 0 |
| NCT05498155 | Phase II | Olaparib Durvalumab + Olaparib | Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (OlympiaN) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 1 |
| 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 |
| 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 |
| 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 |
| NCT03682289 | Phase II | Ceralasertib + Olaparib Olaparib | Phase II Trial of AZD6738 Alone and in Combination With Olaparib | Recruiting | USA | 0 |
| 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 |
| NCT04614909 | Phase I | Olaparib Pamiparib Pamiparib + Temozolomide Olaparib + Pamiparib + Temozolomide | Phase 0/2 Study of Pamiparib in Newly Diagnosed and rGBM | Recruiting | 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 |
| NCT03531840 | Phase II | Olaparib | Olaparib in People With Malignant Mesothelioma | Completed | 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 |
| 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 |
| NCT02677038 | Phase II | Olaparib | Olaparib in Treating Patients With Stage IV Pancreatic Cancer | Completed | USA | 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 |
| NCT04644289 | Phase II | Olaparib Durvalumab + Olaparib | WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC (WoO) | Recruiting | DEU | 0 |
| 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 |
| NCT02983799 | Phase II | Olaparib | Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status | Completed | USA | CAN | 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 |
| 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 |
| NCT05501548 | Phase II | Olaparib | Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer | Recruiting | USA | 0 |
| 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 |
| 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 |
| 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 | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 11 |
| 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 |
| 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 |
| 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 |
| NCT03598257 | Phase II | Olaparib | Radiation Therapy With or Without Olaparib in Treating Participants With Inflammatory Breast Cancer | Recruiting | USA | CAN | 1 |
| 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 |
| NCT03570476 | Phase II | Olaparib | Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer | Terminated | USA | 0 |
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