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
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
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 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
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
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
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
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
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
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 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
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
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
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
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 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
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
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
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
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
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...
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
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 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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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
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
NCT03617679 Phase I Rucaparib Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer Active, not recruiting USA 0
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
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
NCT03533946 Phase II Rucaparib Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) Terminated 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 Completed USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 1
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
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
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
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
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
NCT04676334 Phase III Rucaparib CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib (CATCH-R) Completed ITA | GBR | CAN 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
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
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
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
NCT02678182 Phase II Durvalumab Rucaparib Capecitabine Trastuzumab Capecitabine + Ramucirumab Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM) Recruiting GBR 0
NCT02042378 Phase II Rucaparib A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation Completed USA 1
NCT03572478 Phase Ib/II Nivolumab + Rucaparib Nivolumab Rucaparib Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer Terminated USA 0
NCT03318445 Phase I Rucaparib Irinotecan + Rucaparib Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair Completed 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
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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