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) 21 | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| STAG2 N357fs | glioblastoma | sensitive | Rucaparib | Preclinical - Cell culture | Actionable | In a preclinical study, a glioblastoma cell line harboring a STAG2 mutation (reported as STAG2 N357fs, PMID: 21852505), demonstrated increased sensitivity to treatment with Rubraca (rucaparib) in culture compared to isogenic cells with wild-type STAG2 (PMID: 24356817). | 21852505 24356817 |
| Unknown unknown | ovarian carcinoma | not applicable | Rucaparib | Phase II | Actionable | In a Phase II trial, Rubraca (rucaparib) demonstrated activity in patients with platinum-sensitive high-grade ovarian carcinoma, with patients in the BRCA mutant and BRCA wild-type with high genomic loss-of-heterozygosity subgroups demonstrating increased progression-free survival compared to the BRCA wild-type with low genomic loss-of-heterozygosity subgroup (PMID: 27908594). | 27908594 |
| FANCA inact mut | prostate cancer | predicted - sensitive | Rucaparib | Case Reports/Case Series | Actionable | In a Phase II trial, 1 of 4 patients with deleterious FANCA alterations demonstrated a PSA response and complete radiographic response, which were ongoing at the time of visit cutoff (PMID: 32086346; NCT02952534). | 32086346 |
| 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 |
| Unknown unknown | ovarian cancer | not applicable | Rucaparib | FDA approved | Actionable | In a Phase III trial that supported FDA approval, Rubraca (rucaparib) maintenance therapy significantly improved median progression-free survival compared to placebo (10.8 vs 5.4 mo, HR=0.36, p<0.0001) in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who responded to platinum-based therapy (PMID: 28916367; NCT01968213). | 28916367 |
| Unknown unknown | Advanced Solid Tumor | not applicable | Rucaparib | Phase I | Actionable | In a Phase I trial, Rubraca (rucaparib) was well-tolerated and demonstrated preliminary efficacy, with a disease control rate of 86% (6/7), in patients with advanced solid tumors (J Clin Oncol 31, 2013 (suppl; abstr 2585)). | detail... |
| 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 |
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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 |
| NCT03617679 | Phase I | Rucaparib | Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT03572478 | Phase Ib/II | Nivolumab + Rucaparib Nivolumab Rucaparib | Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer | Terminated | 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 |
| 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 |
| 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 | 19 |
| NCT03397394 | Phase II | Rucaparib | Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS) | Terminated | USA | 5 |
| NCT02952534 | Phase II | Rucaparib | A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2) | Active, not recruiting | USA | CAN | 10 |
| NCT03318445 | Phase I | Rucaparib Irinotecan + Rucaparib | Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair | 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 |
| NCT03911453 | Phase I | Rucaparib | Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors | Recruiting | USA | 0 |
| 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 |
| NCT03533946 | Phase II | Rucaparib | Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) | Recruiting | USA | 0 |
| 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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