25 completed. 25 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 25 |
| Phase 2 | 6 | Completed 6 |
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 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 |
| 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 |
| 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 |
| Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors SYD985 + Niraparib - Solid Tumor | Phase 1 | Completed | Byondis B.V. | 32 | 2020-06-22 | 2024-01-05 |
| Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA) Niraparib plus Cabozantinib - Urothelial Cancer | Phase 1 / Phase 2 | Completed | Fundacion CRIS de Investigación para Vencer el Cáncer | 67 | 2019-10-14 | 2024-12-31 |
| Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring Gonadotrophin Releasing Hormone, Intensity-Modulated Radiation Therapy, Niraparib - Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8 | Phase 1 / Phase 2 | Completed | NRG Oncology | 22 | 2019-10-08 | 2026-07-10 |
| Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Copanlisib, Niraparib - Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation | Phase 1 | Completed | M.D. Anderson Cancer Center | 31 | 2019-04-29 | 2026-07-23 |
| A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer Cobimetinib, Niraparib, Atezolizumab - OVARIAN CANCER | Phase 1 | Completed | Hoffmann-La Roche | 77 | 2019-01-09 | 2023-08-14 |
| Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer Niraparib - Neoplasms, Breast | Phase 1 | Completed | Tesaro, Inc. | 21 | 2018-04-12 | 2025-01-08 |
| A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors Niraparib - Advanced Solid Tumors | Phase 1 | Completed | Takeda | 9 | 2018-04-05 | 2021-11-09 |
| Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients Niraparib - Ovarian Neoplasms, Neoplasms | Phase 1 | Completed | Tesaro, Inc. | 17 | 2018-02-20 | 2021-05-28 |
| Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy Niraparib + Nivolumab, Niraparib + Ipilimumab - Pancreatic Adenocarcinoma | Phase 1 / Phase 2 | Completed | University of Pennsylvania | 104 | 2018-01-31 | 2025-10-10 |
| The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer ZL-2306 (niraparib) - Ovarian Cancer | Phase 1 | Completed | Zai Lab (Shanghai) Co., Ltd. | 42 | 2017-12-19 | 2019-01-24 |
| Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule Niraparib Tablet, Niraparib Capsule - Neoplasms | Phase 1 | Completed | Tesaro, Inc. | 236 | 2017-12-04 | 2024-07-25 |
| Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 Niraparib, TSR-042, Carboplatin-Paclitaxel - Neoplasms, Metastatic Cancer | Phase 1 | Completed | Tesaro, Inc. | 60 | 2017-10-12 | 2025-11-25 |
| Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad) Niraparib, Radium Ra 223 Dichloride - Prostate Carcinoma Metastatic to the Bone, Stage IV Prostate Adenocarcinoma | Phase 1 | Completed | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 14 | 2017-09-22 | 2025-04-29 |
| Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast niraparib, everolimus - Breast Cancer, Ovarian Cancer | Phase 1 | Completed | Avera McKennan Hospital & University Health Center | 14 | 2017-07-26 | 2024-08-01 |
| A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE) Niraparib, Apalutamide, Abiraterone Acetate - Prostatic Neoplasms | Phase 1 | Completed | Janssen Research & Development, LLC | 34 | 2016-10-03 | 2020-07-20 |
| Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer niraparib, pembrolizumab - Neoplasms, Triple Negative Breast Cancer | Phase 1 / Phase 2 | Completed | Tesaro, Inc. | 122 | 2016-04-15 | 2022-12-01 |
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Ovarian Neoplasms (9) · Neoplasms (6) · Breast Neoplasms (4) · Fallopian Tube Neoplasms (3) · Prostatic Neoplasms (3) · Neoplasm Metastasis (2) · Adnexal Diseases (1) · Carcinoma, Non-Small-Cell Lung (1) · Disease Progression (1) · Endocrine Gland Neoplasms (1) · Endocrine System Diseases (1) · Endometrial Neoplasms (1) · Genital Diseases, Female (1) · Genital Diseases, Male (1) · Genital Neoplasms, Female (1)
Tesaro, Inc. (7) · Artios Pharma Ltd (1) · Avera McKennan Hospital & University Health Center (1) · Byondis B.V. (1) · Dantari, Inc. (1) · Fundacion CRIS de Investigación para Vencer el Cáncer (1) · Hoffmann-La Roche (1) · Janssen Research & Development, LLC (1) · K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc (1) · M.D. Anderson Cancer Center (1) · Merck Sharp & Dohme LLC (1) · NRG Oncology (1) · Nordic Society of Gynaecological Oncology - Clinical Trials Unit (1) · OHSU Knight Cancer Institute (1) · Sarcoma Alliance for Research through Collaboration (1)
United States (17) · United Kingdom (3) · Canada (2) · Netherlands (2) · Spain (2) · Belgium (1) · China (1) · Denmark (1) · France (1) · Italy (1) · Japan (1)
Albert Font, MD (1) · Alexandra Zimmer, M.D. (1) · Casey Williams (1) · Daniel Castellano, MD (1) · Erika Hamilton, MD (1) · M. D Michaelson (1) · Mansoor R Mirza, MD (1) · Norbert Koper (1) · Rashmi Chugh, MD (1) · Sandra Strauss, MBBS, PhD (1) · Shannon N Westin (1) · Shefali Agarwal, MD (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 35810751, PMID 37185961, PMID 37644890, PMID 38288862, PMID 38427930, PMID 39019698, PMID 40016438, PMID 41528970
2016 (1), 2017 (1), 2018 (1), U10CA180868 (1)