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Table 5 Ongoing clinical trials of niraparib alone or in combination with other agents for treatment of various malignancies [62]

From: PARP inhibitors as potential therapeutic agents for various cancers: focus on niraparib and its first global approval for maintenance therapy of gynecologic cancers 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
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
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
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
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
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
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
Evaluate DLT Recruiting
NCT02354131 Niraparib versus niraparib-bevacizumab combination in women with platinum-sensitive epithelial ovarian cancer (AVANOVA) Ovarian cancer Phase I/II Niraparib
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
  1. Abbreviations: ORR Objective response rate, DLT dose limiting toxicity, MTD maximum tolerated dose, HRD homologous recombination deficiency, TNBC triple negative breast cancer, CRPC castaration resistant prostate cancer, HER2 human epethilial growth factor receptor 2 negative