Table 5 Ongoing clinical trials of niraparib alone or in combination with other agents for treatment of various malignancies [62]
ClinicalTrials.gov Identifier | Title | Conditions under study | Phase | Interventions (Experimental arms) | Primary outcome measures of niraparib | Recruitment status |
|---|---|---|---|---|---|---|
NCT03209401 | Niraparib plus carboplatin in patients with HRD advanced solid tumor malignancies | Solid malignancies in adult patients with evidence of HRD | Phase 1 | Niraparib Carboplatin | The dose of niraparib required to combine with carboplatin | Not yet recruiting |
NCT03076203 | Phase IB Trial of Radium-223 and niraparib in patients with CRPC (RAPARP) | Prostate carcinoma metastatic to the bone Stage IV prostate adenocarcinoma Hormone-refractory prostate cancer | Phase I | Niraparib Radium Ra 223 Dichloride | To determine MTD to combine with radiation | Not yet recruiting |
NCT02500901 | Enzalutamide and niraparib in the treatment of CRPC | Metastatic prostate pancer | Phase I | Enzalutamide Niraparib | MTD | Active, but not recruiting |
NCT03154281 | Evaluation of the safety and tolerability of niraparib with everolimus in ovarian and breast cancer | Breast cancer Ovarian cancer | Phase I | Niraparib Everolimus | MTD | Not yet recruiting |
NCT02044120 | ESP1/SARC025 global collaboration: a phase I study of a combination of the PARP inhibitor, niraparib and temozolomide or irinotecan in patients with previously treated, incurable Ewing sarcoma | Ewing sarcoma | Phase I | Niraparib Temozolomide Irinotecan | DLT and MTD | Recruiting |
NCT02924766 | A safety and pharmacokinetics study of niraparib plus an androgen receptor-targeted therapy in men with metastatic CRPC (BEDIVERE) | Prostatic neoplasms | Phase I | Niraparib Apalutamide Abiraterone Acetate Prednison | Determine Recommended Phase 2 dose | Recruiting |
NCT03207347 | A Trial of niraparib in BAP1 and Other DNA DSB repair deficient neoplasms (UF-STO-ETI-001) | Mesothelioma Uveal melanoma Renal cell carcinoma Cholangiocarcinoma | Phase II | Niraparib | ORR | Not yet recruiting |
NCT02657889 | Study of niraparib in combination with pembrolizumab (MK-3475) in patients with TNBC or Ovarian Cancer (TOPACIO) | TNBC Ovarian cancer Stage IV breast cancer Fallopian tube cancer Peritoneal cancer | Phase I/II | Niraparib Pembrolizumab | Evaluate DLT | Recruiting |
NCT02354131 | Niraparib versus niraparib-bevacizumab combination in women with platinum-sensitive epithelial ovarian cancer (AVANOVA) | Ovarian cancer | Phase I/II | Niraparib Bevacizumab | PFS | Recruiting |
NCT02854436 | An efficacy and safety study of niraparib in men with metastatic CRPC and DNA-Repair anomalies (Galahad) | Prostatic neoplasms | Phase II | Niraparib | ORR | Suspended |
NCT02354586 | A study of niraparib in patients with ovarian cancer who have received three or four previous chemotherapy regimens (QUADRA) | Ovarian cancer | Phase II | Niraparib | Evaluation of antitumor activity | Recruiting |
NCT01905592 | A phase III trial of niraparib versus physician’s choice in HER2-, germline BRCA mutation-positive breast cancer patients (BRAVO) | Breast cancer HER 2-breast cancer BRCA1/2 gene mutation | Phase III | Niraparib Physician’s choice | PFS | Active, but not recruiting |
NCT02655016 | A study of niraparib maintenance treatment in patients with advanced ovarian cancer following response on front-line platinum-based chemotherapy | Ovarian cancer | Phase III | Niraparib | PFS | Recruiting |