Table 4.
Recently Completed Prostate Cancer Clinical Trials Testing Rucaparib
| Clinicaltrials.Gov Identification Number and Name (if applicable) | Phase of and Type of Clinical Trial | Condition Treated and Details (if Applicable) | Mutations Tested (if Applicable) | Interventions Tested (Arms) | Start Date | Projected Primary Completion Date |
|---|---|---|---|---|---|---|
| NCT02711137a | Phase I/II | Any solid tumor or lymphoma with any alteration relevant to BET protein signalling. This list includes but is not limited to the following: Pancreatic Adenocarcinoma, mCRPC, Breast Cancer, High-grade Serious Ovarian Cancer, Glioblastoma Multiforme, Non-Hodgkin Lymphoma, Ewing Sarcoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelofibrosis | N/A | Various doses of INCB057643 to find maximal tolerable dose or pharmacologically active dose, and then combined INCB057643 with the following compounds separately (groups separated by commas): Gemcitabine, Paclitaxel, Rucaparib, Abiraterone and Prednisone, Ruxolitinib, Azacitidine | May 2016 | February 2019 |
| TRITON2, NCT02952534 | Phase II, single-arm, open-label | mCRPC with 1–2 previous ARAT and 1 prior taxane chemotherapy | Somatic or germline mutation in BRCA1/2, ATM, CDK12, CHEK2, and other not listed mutations in HRR genes | Rucaparib | February 2017 | July 2021 |
| CheckMate 9KD, NCT03338790 | Phase II, multi-arm, open-label | mCRPC with varying previous therapies (1–2 taxane chemotherapies with up to 2 ARAT, 1–2 prior ARAT, or abiraterone without enzalutamide or aplutamide) | N/A | Nivolumab and Rucaparib vs Nivolumab and Docetaxel and Prednisone vs Nivolumab and enzalutamide | December 2017 | January 2021 |
| NCT03572478b | Phase Ib/IIb, multi-arm, open-label | Prostate Cancer with ≥1 ARAT including abiraterone or enzalutamide, Endometrial Cancer | N/A | Rucaparib and Nivolumab vs Rucaparib vs Nivolumab vs Rucaparib initially and then Rucaparib and Nivolumab | August 2018 | February 2020 |
| NCT03840200c | Phase Ib, single-arm with multiple dose measurements | Breast Cancer, Prostate Cancer, Ovarian Cancer | N/A | Ipatasertib and Rucaparib with varying doses — goal is to find maximal tolerable dose to then test in Part 2 of study. | June 2019 | December 2021 |
Notes: aStudy was terminated due to safety concerns.65 bStudy was terminated due to a lack of efficacy.63 cStudy was supposed to continue to Phase II but was stopped as the intervention was found to not show clinically relevant activity against mCRPC.62 Data from these studies.57,66–68,74,75
Abbreviations: BET, bromodomain and extraterminal; mCRPC, metastatic castrate-resistant prostate cancer; ARAT, androgen receptor-axis-targeted therapies; HRR, homologous recombination repair.