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, 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) 27 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, 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
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
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
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
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 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
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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04227522 Phase III Rucaparib Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients (MAMOC) Recruiting DEU 0
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 | FRA | ESP | DEU | CAN | BEL 5
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) Recruiting 1
NCT03397394 Phase II Rucaparib Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS) Terminated USA | ITA | FRA | ESP | DEU 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
NCT02042378 Phase II Rucaparib A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation Completed USA 1
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
NCT03533946 Phase II Rucaparib Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) 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 Active, not recruiting USA | ITA | ESP | CAN 8
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 | ITA | FRA | ESP | DEU | CAN | BEL 4
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
NCT02678182 Phase II Durvalumab Rucaparib Capecitabine Trastuzumab Capecitabine + Ramucirumab Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM) Recruiting 1
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
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 | FRA | ESP | CAN 2
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 | ESP | CAN 2
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) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 5
NCT04676334 Phase III Rucaparib CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib (CATCH-R) Enrolling by invitation USA | ITA | ESP | CAN 7
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
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 | ITA | ESP | DEU | CAN | BEL 18
NCT03617679 Phase I Rucaparib Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer Recruiting 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
NCT03572478 Phase Ib/II Nivolumab + Rucaparib Nivolumab Rucaparib Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer Terminated USA 0


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