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 as maintenance therapy in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring a deleterious BRCA mutation, and for treatment in patients with metastatic castration-resistant prostate cancer harboring a deleterious BRCA mutation (germline and/or somatic) who received anti-androgen therapy and a taxane-based therapy (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) 30 | 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 maintenance therapy in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring a deleterious BRCA mutation, and for treatment in patients with metastatic castration-resistant prostate cancer harboring a deleterious BRCA mutation (germline and/or somatic) 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 |
|---|---|---|---|---|---|---|---|
| PALB2 inact mut | biliary tract cancer | sensitive | Rucaparib | Guideline | Actionable | Rubraca (rucaparib) is included in guidelines as second or later-line therapy for patients with biliary tract cancer harboring BRCA1/2 mutations (PMID: 36372281; ESMO.org). | detail... 36372281 |
| 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 |
| 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 |
| 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 |
| PALB2 mutant | pancreatic adenocarcinoma | sensitive | Rucaparib | Guideline | Actionable | Rubraca (rucaparib) is included in guidelines as maintenance therapy following prior platinum-based therapy for patients with metastatic pancreatic adenocarcinoma harboring germline PALB2 mutations (NCCN.org). | detail... |
| ATM inact mut | prostate cancer | no benefit | Rucaparib | Phase III | Actionable | In a Phase III trial (TRITON3), Rubraca (rucaparib) treatment demonstrated limited efficacy compared to control treatment with Taxotere (docetaxel) in patients with metastatic castration-resistant prostate cancer harboring deleterious ATM mutations, with a median imaging-based progression-free survival of 8.1 months vs. 6.8 months (HR=0.95), a median overall survival of 21.1 months vs. 21.7 months of patients (PMID: 36795891; NCT02975934). | 36795891 |
| 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 |
| CDK12 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 CDK12 mutation presumed to be inactivating, with no confirmed radiographic responses in 10 evaluable patients and a PSA response in 1 patient with biallelic CDK12 alterations in the overall population of 15 patients, and a clinical benefit rate of 20% (3/15) at 6 months and 7.1% (1/14) at 12 months (PMID: 32086346; NCT02952534). | 32086346 |
| PALB2 inact mut | prostate cancer | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a Phase II trial (TRITON2), 2 of 2 patients with metastatic castrate-resistant prostate cancer harboring deleterious PALB2 alterations demonstrated a PSA response after treatment with Rubraca (rucaparib), with one of those patients demonstrating partial radiographic response that was ongoing 3.9 months, and the other a 47% reduction in tumor volume (PMID: 32086346; NCT02952534). | 32086346 |
| PTEN Y174H PTEN K263* | colorectal cancer | predicted - sensitive | Rucaparib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Rubraca (rucaparib) inhibited cell proliferation in a patient-derived colorectal cancer organoids harboring PTEN Y174H and K263*, along with PIK3CA N1068fs, in culture (PMID: 32376656). | 32376656 |
| 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 |
| ARID1A dec exp | breast cancer | sensitive | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, Rubraca (rucaparib) 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 |
| BRIP1 inact mut | prostate cancer | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a Phase II trial (TRITON2), 1 of 2 patients with metastatic castrate-resistant prostate cancer harboring deleterious BRIP1 alterations 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 |
| 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 |
| 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), a patient with metastatic castrate-resistant prostate cancer 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 |
| ARID1A Q456* | colorectal cancer | sensitive | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, Rubraca (rucaparib) treatment resulted in increased apoptosis of colorectal cancer cells harboring ARID1A Q456* in culture (PMID: 26069190). | 26069190 |
| FANCA inact mut | prostate cancer | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a Phase II trial, 1 of 4 patients with metastatic castrate-resistant prostate cancer harboring deleterious FANCA alterations demonstrated a PSA response and complete radiographic response after treatment with Rubraca (rucaparib), which were ongoing at the time of visit cutoff (PMID: 32086346; NCT02952534). | 32086346 |
| 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 |
| 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 |
| PALB2 inact mut | pancreatic cancer | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a Phase II trial, maintenance Rubraca (rucaparib) resulted in a median progression-free survival (mPFS) of 13.1 months and an objective response rate (ORR) of 41.7% (15/36, 3 complete responses, 12 partial responses) in patients with platinum-sensitive, advanced pancreatic cancer harboring deleterious mutations in BRCA1/2 or PALB2, ORR was 50% (3/6) in patients with PALB2 mutations (PMID: 33970687; NCT03140670). | 33970687 |
| 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 |
| 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 | GBR | ESP | CAN | 1 |
| NCT03542175 | Phase I | Rucaparib | A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy | Active, not recruiting | USA | 0 |
| 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 | NZL | ITA | GBR | ESP | DEU | CAN | BEL | AUS | 15 |
| NCT03533946 | Phase II | Rucaparib | Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) | Terminated | USA | 0 |
| 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) | Active, not 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 |
| 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 | Completed | USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 1 |
| NCT03413995 | Phase II | Rucaparib | Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH) | Active, not recruiting | USA | 0 |
| NCT03617679 | Phase I | Rucaparib | Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer | Active, not recruiting | USA | 0 |
| NCT03397394 | Phase II | Rucaparib | Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS) | Terminated | USA | ITA | GBR | FRA | ESP | DEU | 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 | Completed | USA | ITA | GBR | ESP | CAN | 7 |
| NCT04676334 | Phase III | Rucaparib | CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib (CATCH-R) | Completed | ITA | GBR | CAN | 3 |
| NCT03318445 | Phase I | Rucaparib Irinotecan + Rucaparib | Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair | Completed | 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 3 |
| 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) | Completed | USA | GBR | FRA | ESP | CAN | AUS | 0 |
| NCT03572478 | Phase Ib/II | Nivolumab + Rucaparib Nivolumab Rucaparib | Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer | Terminated | USA | 0 |
| NCT02975934 | Phase III | Rucaparib Docetaxel Enzalutamide Abiraterone | A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 3 |
| NCT03140670 | Phase II | Rucaparib | Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy | Terminated | USA | 0 |
| NCT02925234 | Phase II | Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab | The Drug Rediscovery Protocol (DRUP Trial) (DRUP) | Recruiting | NLD | 0 |
| NCT03911453 | Phase I | Rucaparib | Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors | Active, not recruiting | USA | 0 |
| NCT03654833 | Phase II | Bemcentinib + Pembrolizumab Rucaparib Abemaciclib Atezolizumab + Bevacizumab Dostarlimab-gxly + Niraparib | Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma (MiST) | Active, not recruiting | GBR | 0 |
| NCT04227522 | Phase III | Rucaparib | Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients (MAMOC) | Active, not recruiting | DEU | 0 |
| NCT02678182 | Phase II | Durvalumab Rucaparib Capecitabine Trastuzumab Capecitabine + Ramucirumab | Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM) | Recruiting | GBR | 0 |
| NCT04171700 | Phase II | Rucaparib | A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) | Terminated | USA | 0 |
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