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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