30 completed, 23 recruiting, 20 active not recruiting, 17 terminated. 119 Phase 2, 20 Phase 1, 2 Phase 3.
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 |
|---|---|---|---|---|---|---|
| Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Abiraterone Acetate - Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation | Phase 2 | Withdrawn | Qian Qin | 2025-10-01 | 2026-04-08 | |
| 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 |
| Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy Niraparib, FOLFIRI, Ipilimumab - Pancreatic Adenocarcinoma Metastatic | Phase 2 | Recruiting | Abramson Cancer Center at Penn Medicine | 68 | 2025-05-07 | 2026-10-13 |
| Race Impact on Efficacy of Niraparib Plus Abiraterone Acetate and Prednisone in Patients With Homologous Repair Deficient Castration-resistant Prostate Cancer Niraparib/Abirate rone acetate fixed-dose combination, Prednisone - Prostate Cancer, Castrate Resistant Prostate Cancer | Phase 2 | Withdrawn | Latin American Cooperative Oncology Group | 2025-04-30 | 2025-09-29 | |
| 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Niraparib - Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma | Phase 1 / Phase 2 | Withdrawn | City of Hope Medical Center | 2025-04-18 | 2025-05-23 | |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 Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers Niraparib, Dostarlimab - MMR-D/MSI-H Colorectal Cancers | Phase 2 | Withdrawn | Ibrahim Halil Sahin | 2025-01-31 | 2025-02-03 | |
| Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression Niraparib oral tablets - Ovarian Cancer, Oligometastatic Disease | Phase 2 | Recruiting | MedSIR | 30 | 2024-12-03 | 2026-04-22 |
| Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) Tuvusertib (M1774), Niraparib, Lartesertib (M4076) - Ovarian Cancer | Phase 2 | Completed | EMD Serono Research & Development Institute, Inc. | 63 | 2024-10-30 | 2026-09-14 |
| 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 |
| SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy Niraparib oral capsule, SBRT - Ovarian Cancer Recurrent | Phase 2 | Recruiting | Institute of Cancer Research, United Kingdom | 42 | 2024-06-20 | 2026-07-13 |
| High-Risk Metachronous Oligometastatic Prostate Cancer Trial niraparib/abiraterone acetate, Stereotactic ablative radiation therapy (SABR), Androgen deprivation therapy (ADT) - Prostate Cancer, Oligometastatic Disease | Phase 2 | Active not recruiting | University of Maryland, Baltimore | 88 | 2024-04-17 | 2026-05-06 |
| CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations Abiraterone Acetate/Niraparib, Biospecimen Collection, Bone Scan - Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma | Phase 2 | Terminated | Mayo Clinic | 8 | 2024-03-05 | 2026-07-22 |
| Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency Niraparib - Efficacy | Phase 2 | Not yet recruiting | Korea University Anam Hospital | 33 | 2024-02-27 | 2024-02-01 |
| Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC Niraparib - SCLC,Extensive Stage, SLFN11-positive | Phase 2 | Recruiting | ETOP IBCSG Partners Foundation | 44 | 2023-12-20 | 2026-05-29 |
| Niraparib for the Treatment of Leiomyosarcoma Niraparib Tosylate Monohydrate - Locally Advanced Leiomyosarcoma, Metastatic Leiomyosarcoma | Phase 2 | Withdrawn | David Liebner, MD | 2023-12-01 | 2023-09-18 | |
| 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 |
| Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab Niraparib - Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma | Phase 2 | Recruiting | Peking University Cancer Hospital & Institute | 116 | 2023-11-01 | 2026-10-01 |
| Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi Niraparib, Dostarlimab - Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer | Phase 2 | Withdrawn | AGO Research GmbH | 2023-11-01 | 2025-04-06 | |
| 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 |
| Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma Biospecimen Collection, Computed Tomography, Dostarlimab - Recurrent Endometrial Serous Adenocarcinoma | Phase 2 | Active not recruiting | Casey Cosgrove | 8 | 2023-10-17 | 2026-03-27 |
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Ovarian Neoplasms (32) · Fallopian Tube Neoplasms (12) · Breast Neoplasms (11) · Prostatic Neoplasms (10) · Neoplasms (9) · Endometrial Neoplasms (6) · Pancreatic Neoplasms (5) · Lung Neoplasms (4) · Neoplasm Metastasis (4) · Small Cell Lung Carcinoma (4) · Triple Negative Breast Neoplasms (4) · Carcinoma, Ovarian Epithelial (3) · Glioblastoma (3) · Head and Neck Neoplasms (3) · Mesothelioma (3)
Tesaro, Inc. (9) · M.D. Anderson Cancer Center (4) · Abramson Cancer Center at Penn Medicine (3) · Massachusetts General Hospital (3) · University Health Network, Toronto (3) · University of Oklahoma (3) · ARCAGY/ GINECO GROUP (2) · Dana-Farber Cancer Institute (2) · EMD Serono Research & Development Institute, Inc. (2) · GlaxoSmithKline (2) · Gustave Roussy, Cancer Campus, Grand Paris (2) · Janssen Research & Development, LLC (2) · Mayo Clinic (2) · MedSIR (2) · Peking Union Medical College Hospital (2)
United States (56) · China (15) · Spain (15) · Canada (14) · France (13) · Italy (13) · United Kingdom (8) · Belgium (5) · Denmark (5) · Germany (4) · Israel (4) · Netherlands (4) · Japan (3) · South Korea (3) · Australia (2)
Albert Font, MD (1) · Alberto Puccini (1) · Alberto Sobrero (1) · Amit M Oza, M.D. (1) · Amit Oza, MD (1) · Ana Aparicio (1) · Anish Thomas, MD (1) · Antonio Llombart (1) · Carl M Gay, MD,PHD (1) · Casey Cosgrove, MD (1) · Daniel Castellano, MD (1)
PMID 37185961, PMID 40016438, PMID 21796368, PMID 22198468, PMID 22623692, PMID 22649152, PMID 27406346, PMID 27406347, PMID 28851423, PMID 30307465, PMID 31194225, PMID 31194228, PMID 31375879, PMID 31474354, PMID 32031889, PMID 32053137, PMID 32193378, PMID 32319233, PMID 32450725, PMID 32701140, PMID 33327047, PMID 33470063, PMID 33515503, PMID 34083331, PMID 34529000, PMID 34741021, PMID 35086719, PMID 35131040, PMID 35157829, PMID 35402241, PMID 35443252, PMID 35568909, PMID 35598186, PMID 35623341, PMID 35810751, PMID 35993306, PMID 36069821, PMID 36456573, PMID 36583171, PMID 36710203, PMID 36814246, PMID 36870947, PMID 37029329, PMID 37325931, PMID 37404070, PMID 37424386, PMID 37505107, PMID 37650734, PMID 37651261, PMID 37890345
2017 (5), 2023 (3), 2016 (1), P30CA033572 (1), P30CA093373 (1), P30CA138292 (1), U10CA180868 (1)