25 completed, 14 terminated, 10 active not recruiting, 5 withdrawn. 60 Phase 1, 20 Phase 2.
Follow niraparib: new trials by email Literature Review of niraparib trials Research Report on niraparib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours LM-2417, Docetaxel, Toripalimab/Tirelizumab - Advanced Solid Tumor | Phase 1 / Phase 2 | Recruiting | LaNova Medicines Limited | 320 | 2025-09-17 | 2026-08-28 |
| Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer Biopsy, Biospecimen Collection, Niraparib - Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma | Phase 1 / Phase 2 | Withdrawn | City of Hope Medical Center | 2025-04-18 | 2025-05-23 | |
| Niraparib and Temozolomide in Patients Glioblastoma Temodal, Niraparib - Glioma, Malignant | Phase 1 / Phase 2 | Not yet recruiting | Armando Santoro, MD | 86 | 2024-09-01 | 2024-08-30 |
| ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors ZEN003694, Niraparib - Ovarian Cancer, Recurrent Solid Tumors | Phase 1 | Withdrawn | Haider Mahdi | 2024-01-23 | 2024-10-15 | |
| Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma Dostarlimab, Niraparib, cisplatin plus radiotherapy - Head and Neck Squamous Cell Carcinoma | Phase 1 / Phase 2 | Active not recruiting | Grupo Español de Tratamiento de Tumores de Cabeza y Cuello | 34 | 2023-11-13 | 2026-06-04 |
| A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors GSK4524101, Niraparib - Neoplasms | Phase 1 / Phase 2 | Active not recruiting | GlaxoSmithKline | 42 | 2023-10-24 | 2026-04-24 |
| Reirradiation and Niraparib in Patients With Recurrent Glioblastoma Niraparib, Re-irradiation (re-RT) - Recurrent Glioblastoma | Phase 1 | Withdrawn | University College, London | 2023-10-13 | 2024-03-26 | |
| Combination Therapy in Cancers With Mutations in DNA Repair Genes Niraparib, Irinotecan - Metastatic Solid Tumor, BRCA1 Mutation | Phase 1 | Recruiting | University of California, San Francisco | 24 | 2023-05-23 | 2026-06-18 |
| A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers Niraparib, Dostarlimab, Short course radiation - Rectal Neoplasms, Rectal Neoplasm Malignant | Phase 1 | Terminated | University of Iowa | 3 | 2022-07-07 | 2026-06-29 |
| A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer DAN-222, Niraparib - HER2-negative Metastatic Breast Cancer | Phase 1 | Completed | Dantari, Inc. | 30 | 2022-02-02 | 2023-12-13 |
| A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer Azenosertib, Niraparib - Ovarian Cancer, Platinum-resistant Ovarian Cancer | Phase 1 / Phase 2 | Completed | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | 117 | 2022-01-27 | 2026-03-18 |
| Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Dostarlimab, Niraparib, Biopsy - Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 | Phase 1 | Active not recruiting | University of Washington | 18 | 2021-10-18 | 2026-08-20 |
| A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors ART4215, Talazoparib, Niraparib - Advanced Cancer, Metastatic Cancer | Phase 1 | Completed | Artios Pharma Ltd | 93 | 2021-09-13 | 2026-01-27 |
| CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients Cohort 1: Dose Escalation, Cohort 2: Dose Escalation - Ovarian Cancer, Resistant BRCA Wild-Type Ovarian Cancer | Phase 1 | Terminated | University of Alabama at Birmingham | 1 | 2021-09-01 | 2023-11-21 |
| Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors RP-3500 (camonsertib) - Advanced Solid Tumor, Adult | Phase 1 / Phase 2 | Terminated | Repare Therapeutics | 156 | 2021-07-21 | 2025-10-30 |
| Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer Abemaciclib, Niraparib Tosylate Monohydrate - Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8 | Phase 1 | Completed | OHSU Knight Cancer Institute | 8 | 2021-06-07 | 2026-01-29 |
| Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors Niraparib, Anlotinib - HER2-negative Breast Cancer, Gastric Adenocarcinoma | Phase 1 | Unknown | Peking University Cancer Hospital & Institute | 52 | 2021-04-01 | 2021-02-21 |
| LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer Niraparib, Doxorubicin, Cyclophosphamide - Breast Cancer | Phase 1 | Withdrawn | Wake Forest University Health Sciences | 2021-04-01 | 2022-04-26 | |
| Study of M4344 in Combination With Niraparib Niraparib, M4344 - Advanced Solid Tumor, Breast Cancer | Phase 1 / Phase 2 | Withdrawn | EMD Serono Research & Development Institute, Inc. | 2020-12-01 | 2021-06-30 | |
| A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer Niraparib, Abiraterone Acetate (AA), Prednisone - Prostatic Neoplasms | Phase 1 | Active not recruiting | Janssen Research & Development, LLC | 136 | 2020-11-13 | 2026-09-25 |
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Ovarian Neoplasms (18) · Neoplasms (11) · Breast Neoplasms (10) · Prostatic Neoplasms (6) · Fallopian Tube Neoplasms (5) · Neoplasm Metastasis (5) · Carcinoma, Squamous Cell (2) · Glioblastoma (2) · Lung Neoplasms (2) · Pancreatic Neoplasms (2) · Small Cell Lung Carcinoma (2) · Triple Negative Breast Neoplasms (2) · Adnexal Diseases (1) · Anus Neoplasms (1) · Carcinoma (1)
Tesaro, Inc. (9) · EMD Serono Research & Development Institute, Inc. (2) · GlaxoSmithKline (2) · Hoffmann-La Roche (2) · Janssen Research & Development, LLC (2) · Massachusetts General Hospital (2) · Merck Sharp & Dohme LLC (2) · University of Alabama at Birmingham (2) · Armando Santoro, MD (1) · Artios Pharma Ltd (1) · Avera McKennan Hospital & University Health Center (1) · Bayer (1) · Byondis B.V. (1) · City of Hope Medical Center (1) · Dantari, Inc. (1)
United States (38) · United Kingdom (7) · Spain (6) · China (5) · France (4) · Canada (3) · Netherlands (3) · Belgium (2) · Italy (2) · Japan (2) · Denmark (1) · Georgia (1) · Greece (1) · Moldova (1) · Panama (1)
Albert Font, MD (1) · Alexandra Zimmer, M.D. (1) · Alice Ho, MD (1) · Andrew Poklepovic, MD (1) · Anish Thomas, MD (1) · Antoinette Tan, MD (1) · Casey Williams (1) · Claudine Isaacs, MD (1) · Daniel Castellano, MD (1) · Daniel Spratt, M.D. (1) · Dusan Milanovic (1)
PMID 23524863, PMID 23810788, PMID 31194225, PMID 31194228, PMID 31375879, PMID 31439812, PMID 31474354, PMID 32193378, PMID 32379297, PMID 33289920, PMID 33754187, PMID 34324028, PMID 34904813, PMID 35810751, PMID 37185961, PMID 37644890, PMID 37651261, PMID 38288862, PMID 38427930, PMID 38436924, PMID 39019698, PMID 40016438, PMID 40705098, PMID 40838864, PMID 41528970
2018 (2), 2019 (2), 2016 (1), 2017 (1), 2023 (1), P30CA033572 (1), U10CA180868 (1)