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Profile Name | RAD51C inact mut |
Gene Variant Detail | |
Relevant Treatment Approaches | Olaparib |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
RAD51C inact mut | prostate cancer | sensitive | Olaparib | 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 | 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 |
RAD51C inact mut | Advanced Solid Tumor | sensitive | E7449 | Preclinical | Actionable | In a preclinical study, E7449 inhibited proliferation of a RAD51C-deficient cell line in culture, which demonstrated increased sensitivity compared to cells without DNA repair pathway mutations (PMID: 26513298). | 26513298 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT05033756 | Phase II | Olaparib + Pembrolizumab | Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO (COMPRENDO) | Not yet recruiting | DEU | 0 |
NCT04983745 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) | Not yet recruiting | USA | 0 |
NCT04336943 | Phase II | Durvalumab + Olaparib | Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load | Recruiting | USA | 0 |
NCT04171700 | Phase II | Rucaparib | A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) | Active, not recruiting | USA | 0 |
NCT03810105 | Phase II | Durvalumab + Olaparib | A Study of Olaparib and Durvalumab in Prostate Cancer | Active, not recruiting | USA | 0 |
NCT05188508 | Phase II | Olaparib + Pembrolizumab + Temozolomide | Pembrolizumab, Olaparib, and Temozolomide for People With Glioma | Recruiting | USA | 0 |
NCT04266912 | Phase Ib/II | Avelumab + Berzosertib | Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors | Recruiting | USA | 0 |
NCT02734004 | Phase Ib/II | Durvalumab + Olaparib Bevacizumab + Durvalumab + Olaparib | A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (MEDIOLA) | Completed | USA | FRA | 5 |
NCT04550494 | Phase II | Talazoparib | Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations | Recruiting | USA | 0 |
NCT03840967 | Phase II | Niraparib | A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma | Recruiting | USA | 0 |
NCT03992131 | Phase Ib/II | Lucitanib + Rucaparib Rucaparib + Sacituzumab govitecan-hziy | A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR) | Active, not recruiting | USA | 0 |
NCT04693468 | Phase I | Axitinib + Talazoparib Crizotinib + Talazoparib Palbociclib + Talazoparib | Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial | Recruiting | USA | 0 |
NCT03233204 | Phase II | Olaparib | Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) | Active, not recruiting | USA | 1 |
NCT05174455 | Phase II | Niraparib | Niraparib for the Treatment of Leiomyosarcoma | Not yet recruiting | USA | 0 |
NCT04985721 | Phase II | Pamiparib + Tislelizumab | A Trial of Pamiparib With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects (IMPARP-HRD) | Recruiting | 1 | |
NCT04493060 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer | Recruiting | USA | 0 |
NCT04253262 | Phase Ib/II | Copanlisib + Rucaparib | A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer | Recruiting | USA | 0 |
NCT05340413 | Phase II | Olaparib | Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. (RADIOLA) | Recruiting | ESP | 0 |
NCT04019327 | Phase Ib/II | Talazoparib + Temozolomide | A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer | Recruiting | USA | 0 |
NCT03047135 | Phase II | Olaparib | Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis | Recruiting | USA | 0 |
NCT03344965 | Phase II | Olaparib | Olaparib In Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT04666740 | Phase II | Olaparib + Pembrolizumab | A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy | Recruiting | USA | 0 |
NCT02401347 | Phase II | Talazoparib | Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors | Recruiting | USA | 0 |
NCT05417594 | Phase Ib/II | AZD9574 AZD9574 + Temozolomide | Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies (CERTIS1) | Not yet recruiting | USA | ESP | DEU | 4 |
NCT03786796 | Phase II | Olaparib | Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) | Recruiting | USA | 0 |
NCT04276376 | Phase II | Atezolizumab + Rucaparib | Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors (ARIANES) | Recruiting | FRA | 0 |
NCT04826341 | Phase Ib/II | Berzosertib + Sacituzumab govitecan-hziy | A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors | Recruiting | USA | 0 |
NCT04053322 | Phase II | Durvalumab + Fulvestrant + Olaparib | Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) | Recruiting | FRA | 0 |
NCT05010096 | Phase I | BAY1895344 + Copanlisib | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | Withdrawn | 0 |