Therapy Detail
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| Therapy Name | Rucaparib |
| Synonyms | |
| Therapy Description |
Rubraca (rucaparib) binds to and inhibits PARP, which may result in accumulation of DNA damage and chemosensitization of tumor cells (PMID: 17363489). Rubraca (rucaparib) is FDA approved for use in ovarian cancer patients with deleterious somatic and/or germline BRCA mutations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Rucaparib | Rubraca | AG014699|PF-01367338|CO-388|AG14447 | PARP Inhibitor (Pan) 23 | Rubraca (rucaparib) binds to and inhibits PARP, which may result in accumulation of DNA damage and chemosensitization of tumor cells (PMID: 17363489). Rubraca (rucaparib) is FDA approved for use as a maintenance therapy in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, for treatment in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring deleterious somatic and/or germline BRCA mutations who received 2 or more chemotherapies, and in patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who received anti-androgen therapy and a taxane-based therapy (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 RAD51C R193* RAD51C R193L RAD51C R193W | ovarian carcinoma | predicted - resistant | Rucaparib | Case Reports/Case Series | Actionable | In a clinical case study, an ovarian carcinoma patient harboring a RAD51C R193* germline mutation developed resistance to Rubraca (rucaparib) after acquisition of RAD51C R193W, RAD51C H192_R193delinsGG, and RAD51C R193L (PMID: 28588062). | 28588062 |
| RAD51B rearrange | prostate cancer | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a Phase II trial (TRITON2), the patient harboring a RAD51B rearrangement demonstrated a PSA response and partial radiographic response after treatment with Rubraca (rucaparib), which were ongoing at the time of visit cutoff (PMID: 32086346; NCT02952534). | 32086346 |
| RAD51C R193L | ovarian carcinoma | resistant | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, ovarian carcinoma cells expressing RAD51C R193L demonstrated resistance to Rubraca (rucaparib) in culture (PMID: 28588062). | 28588062 |
| RAD51C H192_R193delinsGG | ovarian carcinoma | resistant | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, ovarian carcinoma cells expressing RAD51C H192_R193delinsGG demonstrated resistance to Rubraca (rucaparib) in culture (PMID: 28588062). | 28588062 |
| RAD51D S257_R259delinsK RAD51D G258Sfs*50 | ovarian carcinoma | predicted - resistant | Rucaparib | Case Reports/Case Series | Actionable | In a clinical case study, an ovarian carcinoma patient harboring a RAD51D G258Sfs*50 germline mutation developed resistance to Rubraca (rucaparib) after acquisition of RAD51D S257_R259delinsK (PMID: 28588062). | 28588062 |
| RAD51D G258Sfs*50 | ovarian carcinoma | sensitive | Rucaparib | Preclinical - Cell culture | Actionable | In a clinical study, an ovarian carcinoma patient harboring a RAD51D G258Sfs*50 germline mutation demonstrated stable disease when treated with Rubraca (rucaparib) (PMID: 28588062). | 28588062 |
| IDH1 R132H | Advanced Solid Tumor | sensitive | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, transformed cells over expressing IDH1 R132H demonstrated increased sensitivity to Rubraca (rucaparib)-induced growth inhibition in culture (PMID: 28148839). | 28148839 |
| ATM inact mut | prostate cancer | no benefit | Rucaparib | Phase II | Actionable | In a Phase II trial (TRITON2), activity of Rubraca (rucaparib) was limited in the cohort of patients with metastatic castrate-resistant prostate cancer harboring an ATM mutation presumed to be inactivating, with a radiographic response rate of 10.5% (2/19, including 1 patient with co-occurring CHEK2 alteration) and PSA response rate of 4.1% (2/49), and no radiographic responses in 11 patients with biallelic alterations in ATM or 11 patients with germline ATM alterations (PMID: 32086346; NCT02952534). | 32086346 |
| PTEN del | prostate cancer | sensitive | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, Rubraca (rucaparib) induced senescence and increased radiosensitivity in PTEN null prostate cancer cells in culture (PMID: 23565244). | 23565244 |
| RAD51C R193* | ovarian carcinoma | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a clinical case study, an ovarian carcinoma patient harboring a RAD51C R193* germline mutation demonstrated a partial response when treated with Rubraca (rucaparib) (PMID: 28588062). | 28588062 |
| ATM del | prostate cancer | no benefit | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, ATM-deficient prostate cancer cell lines did not respond to treatment with Rubraca (rucaparib) in culture (PMID: 32127357). | 32127357 |
| CHEK2 inact mut | prostate cancer | no benefit | Rucaparib | Phase II | Actionable | In a Phase II trial (TRITON2), activity of Rubraca (rucaparib) was limited in the cohort of patients with metastatic castrate-resistant prostate cancer harboring a CHEK2 mutation presumed to be inactivating, with a radiographic partial response in 1 patient who had a co-occurring ATM alteration out of 9 evaluable patients, and PSA response rate of 16.7% (2/12), and a clinical benefit rate of 37.5% (3/8) at 6 months, with no patients remaining on treatment at 12 months (PMID: 32086346; NCT02952534). | 32086346 |
| RAD51C R193W | ovarian carcinoma | resistant | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, ovarian carcinoma cells expressing RAD51C R193W demonstrated resistance to Rubraca (rucaparib) in culture (PMID: 28588062). | 28588062 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01891344 | Phase II | Rucaparib | A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) | Active, not recruiting | USA | CAN | 4 |
| NCT03533946 | Phase II | Rucaparib | Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) | Recruiting | USA | 0 |
| NCT03911453 | Phase I | Rucaparib | Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors | Recruiting | USA | 0 |
| NCT02042378 | Phase II | Rucaparib | A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation | Completed | USA | 1 |
| NCT03845296 | Phase II | Rucaparib | Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) | Recruiting | USA | 0 |
| NCT01482715 | Phase Ib/II | Rucaparib | A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II) | Completed | USA | CAN | 3 |
| NCT03413995 | Phase II | Rucaparib | Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH) | Recruiting | USA | 0 |
| NCT04676334 | Phase III | Rucaparib | CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib (CATCH-R) | Enrolling by invitation | CAN | 10 |
| NCT03318445 | Phase I | Rucaparib Irinotecan + Rucaparib | Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair | Completed | USA | 0 |
| NCT04227522 | Phase III | Rucaparib | Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients (MAMOC) | Recruiting | 1 | |
| NCT04171700 | Phase II | Rucaparib | A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) | Recruiting | USA | 0 |
| NCT02975934 | Phase III | Rucaparib Docetaxel Enzalutamide Abiraterone | A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3) | Recruiting | USA | CAN | 10 |
| NCT03397394 | Phase II | Rucaparib | Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS) | Terminated | USA | 5 |
| NCT03617679 | Phase I | Rucaparib | Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer | Recruiting | USA | 0 |
| NCT02855944 | Phase III | Cisplatin Rucaparib Carboplatin Gemcitabine Paclitaxel | ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients | Active, not recruiting | USA | CAN | 10 |
| NCT03572478 | Phase Ib/II | Nivolumab + Rucaparib Nivolumab Rucaparib | Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer | Terminated | USA | 0 |
| NCT03140670 | Phase II | Rucaparib | Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy | Active, not recruiting | USA | 0 |
| NCT03542175 | Phase I | Rucaparib | A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy | Recruiting | USA | 0 |
| NCT02952534 | Phase II | Rucaparib | A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2) | Completed | USA | CAN | 10 |
| NCT03522246 | Phase III | Rucaparib Nivolumab Nivolumab + Rucaparib | A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA) | Active, not recruiting | USA | CAN | 22 |
| NCT01968213 | Phase III | Rucaparib | A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer | Active, not recruiting | USA | CAN | 9 |
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