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) 19 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 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
STAG2 N357fs glioblastoma multiforme 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
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
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
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
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
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
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
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
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
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...

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Clinical Trial Phase Therapies Title Recruitment Status
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
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
NCT03617679 Phase I Rucaparib Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer Recruiting
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
NCT03911453 Phase I Rucaparib Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors Recruiting
NCT03533946 Phase II Rucaparib Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) Recruiting
NCT04171700 Phase II Rucaparib A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR) Recruiting
NCT03413995 Phase II Rucaparib Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH) Recruiting
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
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 Recruiting
NCT03397394 Phase II Rucaparib Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS) Completed
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) Recruiting
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
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
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
NCT03318445 Phase I Rucaparib Irinotecan + Rucaparib Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair Recruiting
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
NCT02042378 Phase II Rucaparib A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation Completed
NCT03572478 Phase Ib/II Nivolumab + Rucaparib Nivolumab Rucaparib Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer Active, not recruiting


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