Clinical Trials

Numerous clinical trials evaluate niraparib across Early Phase 1 through Phase 4 for diverse oncological indications, including platinum-sensitive ovarian, castrate-resistant prostate, and triple-negative breast cancers, as well as advanced solid tumors with homologous recombination deficiency mutations such as BRCA1, BRCA2, and ATM. These studies exhibit varying recruitment statuses, from actively recruiting to completed, and are supported by pharmaceutical companies, academic medical centers, and collaborative research groups.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06915025 RECRUITING
Epithelial Ovarian Cancer; Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
Imunon
 2025-07-09 PHASE3
NCT05460000 RECRUITING
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Clear Cell Carcinoma
North Eastern German Society of Gynaecological Oncology
 2024-10-11 PHASE2
NCT01042379 RECRUITING
Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer
QuantumLeap Healthcare Collaborative
 2010-03-01 PHASE2
NCT05700721 RECRUITING
Brain Metastases
M.D. Anderson Cancer Center
 2023-06-02 PHASE2
NCT05659381 RECRUITING
Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Stage III Primary Peritoneal Cancer; Stage IV Primary Peritoneal Cancer; Stage III Fallopian Tube Cancer; Stage IV Fallopian Tube Cancer
GOG Foundation
 2024-03-08 PHASE3
NCT06412120 RECRUITING
Ovarian Cancer
University of Miami
 2026-07-28 PHASE4
NCT06953323 RECRUITING
Advanced Solid Tumor
Wigen Biomedicine Technology (Shanghai) Co., Ltd.
 2025-07-10 PHASE1; PHASE2
NCT04341181 RECRUITING
Cancer; Tumors; Neoplasms; Neoplasia
Ulrik Lassen
 2020-08-24 PHASE2
NCT06212583 ACTIVE_NOT_RECRUITING
Prostate Cancer; Oligometastatic Disease
University of Maryland, Baltimore
 2024-04-17 PHASE2
NCT06682780 RECRUITING
Advanced Solid Tumor
LaNova Medicines Limited
 2025-09-17 PHASE1; PHASE2
NCT05009082 RECRUITING
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
AGO Study Group
 2022-09-13 PHASE3
NCT03768063 ACTIVE_NOT_RECRUITING
Cancer
Hoffmann-La Roche
 2019-02-28 PHASE3
NCT04947254 RECRUITING
Prostate Carcinoma; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2021-08-05 PHASE2
NCT06747845 RECRUITING
Pancreatic Adenocarcinoma Metastatic
Abramson Cancer Center at Penn Medicine
 2025-05-07 PHASE2
NCT05694715 RECRUITING
Metastatic Solid Tumor; BRCA1 Mutation; BRCA2 Mutation; ATM Gene Mutation; PALB2 Gene Mutation
University of California, San Francisco
 2023-05-23 PHASE1
NCT06392841 WITHDRAWN
Metastatic Hormone-sensitive Prostate Cancer (mHSPC); Deleterious HRR Gene Mutation; BRCA1 Gene Mutation; BRCA2 Gene Mutation; BRIP1 Gene Mutation; CHEK2 Gene Mutation; FANCA Gene Mutation; PALB2 Gene Mutation; RAD51B Gene Mutation; RAD54L Gene Mutation
Qian Qin
 2025-10 PHASE2
NCT06180356 RECRUITING
Ovarian Cancer; Oligometastatic Disease; Serous Ovarian Tumor
MedSIR
 2024-12-03 PHASE2
NCT05601440 RECRUITING
Breast Cancer
Canadian Cancer Trials Group
 2023-06-13 PHASE2
NCT04592237 ACTIVE_NOT_RECRUITING
Aggressive Variant Prostate Carcinoma; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Metastatic Prostate Neuroendocrine Carcinoma; Metastatic Prostate Small Cell Carcinoma; Stage IV Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2020-12-29 PHASE2
NCT05990192 RECRUITING
Ovarian Cancer Recurrent
Institute of Cancer Research, United Kingdom
 2024-06-20 PHASE2
NCT06388733 ACTIVE_NOT_RECRUITING
Glioblastoma; GBM; Brain Neoplasms, Adult, Malignant; Brain Tumor
Ivy Brain Tumor Center
 2024-06-19 PHASE3
NCT03368729 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer; HER2 Positive Breast Carcinoma
University of Alabama at Birmingham
 2019-09-06 PHASE1; PHASE2
NCT06527690 WITHDRAWN
Prostate Cancer; Castrate Resistant Prostate Cancer; Homologous Recombination Deficiency
Latin American Cooperative Oncology Group
 2025-04-30 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT05519670 NOT_YET_RECRUITING
Breast Cancer
Institut Paoli-Calmettes
 2023-03 PHASE1; PHASE2
NCT05515575 ACTIVE_NOT_RECRUITING
Sarcoma,Soft Tissue; Sarcoma Uterus
Memorial Sloan Kettering Cancer Center
 2022-08-23 PHASE2
NCT04812366 RECRUITING
Prostate Cancer
University of British Columbia
 2021-09-21 PHASE2
NCT03651206 RECRUITING
Ovarian Carcinosarcoma; Endometrial Carcinosarcoma
ARCAGY/ GINECO GROUP
 2020-07-15 PHASE2; PHASE3
NCT05615818 RECRUITING
Biliary Tract Neoplasms
UNICANCER
 2024-07-18 PHASE3
NCT04194554 ACTIVE_NOT_RECRUITING
Prostate Cancer
University of Michigan Rogel Cancer Center
 2020-11-06 PHASE1; PHASE2
NCT04701307 ACTIVE_NOT_RECRUITING
Lung Small Cell Carcinoma; Neuroendocrine Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8
M.D. Anderson Cancer Center
 2021-02-01 PHASE2
NCT06594679 RECRUITING
Ovarian Cancer
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2024-09-26 PHASE1; PHASE2
NCT05784012 ACTIVE_NOT_RECRUITING
Head and Neck Squamous Cell Carcinoma
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
 2023-11-13 PHASE1; PHASE2
NCT04837209 ACTIVE_NOT_RECRUITING
Breast Cancer; Triple Negative Breast Cancer
Massachusetts General Hospital
 2021-07-21 PHASE2
NCT05183984 RECRUITING
Ovarian Cancer
ARCAGY/ GINECO GROUP
 2022-02-01 PHASE2
NCT03830918 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Extensive Stage Lung Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
Jonsson Comprehensive Cancer Center
 2019-03-06 PHASE1; PHASE2
NCT06365970 WITHDRAWN
MMR-D/MSI-H Colorectal Cancers
Ibrahim Halil Sahin
 2025-01-31 PHASE2
NCT03945721 ACTIVE_NOT_RECRUITING
Triple Negative Breast Cancer; Residual Disease
Massachusetts General Hospital
 2019-07-11 PHASE1
NCT06161493 WITHDRAWN
Ovarian Cancer; Recurrent Solid Tumors
Haider Mahdi
 2024-01-23 PHASE1
NCT05335993 ACTIVE_NOT_RECRUITING
Recurrent Ovarian Cancer; Recurrent Epithelial Cancer of Ovary; Recurrent Epithelial Ovarian Cancer; Recurrent Fallopian Tube Cancer; Peritoneal Cancer; Recurrent Carcinoma of Ovary; Adenocarcinoma of Ovary
CanariaBio Inc.
 2022-07-25 PHASE2
NCT04641247 RECRUITING
Ovarian Neoplasms; Breast Neoplasms
GlaxoSmithKline
 2021-04-16 PHASE2
NCT04992013 ACTIVE_NOT_RECRUITING
Metastatic Cancer; Central Nervous System Cancer
Massachusetts General Hospital
 2022-04-05 PHASE2
NCT05718323 RECRUITING
SCLC,Extensive Stage; SLFN11-positive
ETOP IBCSG Partners Foundation
 2023-12-20 PHASE2
NCT03903835 RECRUITING
Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Karolinska Institutet
 2019-02-01 PHASE3
NCT04068753 ACTIVE_NOT_RECRUITING
Recurrent Cervix Cancer; Progressive Cervix Cancer
University of Oklahoma
 2020-02-26 PHASE2
NCT06258018 NOT_YET_RECRUITING
Glioma, Malignant
Armando Santoro, MD
 2024-09 PHASE1; PHASE2
NCT04170153 ACTIVE_NOT_RECRUITING
Metastatic or Locally Advanced Unresectable Solid Tumors
EMD Serono Research & Development Institute, Inc.
 2019-12-20 PHASE1
NCT05672095 WITHDRAWN
Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
City of Hope Medical Center
 2025-04-18 PHASE1; PHASE2
NCT03981796 ACTIVE_NOT_RECRUITING
Neoplasms
Tesaro, Inc.
 2019-07-18 PHASE3
NCT05526989 RECRUITING
Penile Carcinoma
H. Lee Moffitt Cancer Center and Research Institute
 2022-12-28 PHASE2
NCT06329830 WITHDRAWN
Metastatic Prostate Cancer; Castration-resistant Prostate Cancer; Metastatic Castration-resistant Prostate Cancer
Baptist Health South Florida
 2024-10 PHASE1; PHASE2
NCT06141265 RECRUITING
Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Peking University Cancer Hospital & Institute
 2023-11-01 PHASE2
NCT05689021 TERMINATED
Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8
Mayo Clinic
 2024-03-05 PHASE2
NCT04423185 RECRUITING
Rare Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2020-08-15 PHASE2
NCT05406700 ACTIVE_NOT_RECRUITING
Low-grade Glioma; IDH2 Gene Mutation; Recurrent Glioma; IDH1 Mutation; Glioma, Malignant
Massachusetts General Hospital
 2023-05-18 EARLY_PHASE1
NCT06077877 ACTIVE_NOT_RECRUITING
Neoplasms
GlaxoSmithKline
 2023-10-24 PHASE1; PHASE2
NCT06237205 NOT_YET_RECRUITING
Efficacy
Korea University Anam Hospital
 2024-02-27 PHASE2
NCT03586661 COMPLETED
Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; Endometrial Adenocarcinoma; High Grade Ovarian Serous Adenocarcinoma; Platinum-Resistant Ovarian Carcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Progressive Disease; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
M.D. Anderson Cancer Center
 2019-04-29 PHASE1
NCT06433219 ACTIVE_NOT_RECRUITING
Ovarian Cancer
EMD Serono Research & Development Institute, Inc.
 2024-10-30 PHASE2
NCT05238831 WITHDRAWN
Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
OHSU Knight Cancer Institute
 2023-01-30 EARLY_PHASE1
NCT06887933 NOT_YET_RECRUITING
Ovarian Neoplasms
GlaxoSmithKline
 2025-04-22 PHASE4
NCT04221503 ACTIVE_NOT_RECRUITING
Glioblastoma; Recurrent Glioblastoma; GBM
Abramson Cancer Center at Penn Medicine
 2019-12-30 PHASE2
NCT04762901 WITHDRAWN
Breast Cancer
Wake Forest University Health Sciences
 2021-04-01 PHASE1
NCT04673448 ACTIVE_NOT_RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; BRCA-Associated Malignant Neoplasm; BRCA Hereditary Ovarian Carcinoma; Metastatic BRCA Hereditary Breast Carcinoma; Metastatic Breast Carcinoma; Metastatic Fallopian Tube Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Ovarian Carcinoma; Metastatic Pancreatic Carcinoma; Metastatic Primary Peritoneal Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Stage III Fallopian Tube Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage III Primary Peritoneal Cancer AJCC v8; Stage IV Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; Unresectable Breast Carcinoma; Unresectable Fallopian Tube Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Ovarian Carcinoma; Unresectable Pancreatic Carcinoma; Unresectable Primary Peritoneal Carcinoma
University of Washington
 2021-10-18 PHASE1
NCT04716686 RECRUITING
Endometrial Carcinoma; Serous Carcinoma
Shandong University
 2021-06-01 PHASE2
NCT03601923 COMPLETED
Pancreatic Cancer
Dana-Farber Cancer Institute
 2018-08-22 PHASE2
NCT04991480 COMPLETED
Advanced Cancer; Metastatic Cancer; Breast Cancer
Artios Pharma Ltd
 2021-09-13 PHASE1
NCT05187208 UNKNOWN
Epithelial Ovarian Cancer; Ovarian Cancer; Ovarian Cancer Stage III; Ovarian Cancer Stage IV
Seoul National University Hospital
 2022-01 PHASE4
NCT05289648 WITHDRAWN
Endometrial Cancer; Serous Adenocarcinoma; Uterine Neoplasm
Sir Mortimer B. Davis - Jewish General Hospital
 2024-05-01 EARLY_PHASE1
NCT05198804 COMPLETED
Ovarian Cancer; Platinum-resistant Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
 2022-01-27 PHASE1; PHASE2
NCT03869190 TERMINATED
Urothelial Carcinoma; Bladder Cancer
Hoffmann-La Roche
 2019-06-01 PHASE1; PHASE2
NCT05870761 ACTIVE_NOT_RECRUITING
Recurrent Endometrial Serous Adenocarcinoma
Casey Cosgrove
 2023-10-17 PHASE2
NCT05961124 RECRUITING
Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Ovarian Cancer; High Grade Ovarian Serous Adenocarcinoma
Sunnybrook Health Sciences Centre
 2023-08-21 PHASE2
NCT06036966 UNKNOWN
Thrombocytopenia
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2023-09-16 PHASE2
NCT04584255 ACTIVE_NOT_RECRUITING
Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Breast Cancer; HER2-negative Breast Cancer; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation; Deleterious PALB2 Gene Mutation
Dana-Farber Cancer Institute
 2020-12-18 PHASE2
NCT05065021 UNKNOWN
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; High Grade Serous Cancer; High Grade Endometrioid Cancer
University Health Network, Toronto
 2023-02-23 PHASE2
NCT04313504 COMPLETED
Head and Neck Cancer
Trisha Wise-Draper
 2020-11-04 PHASE2
NCT03088059 UNKNOWN
Carcinoma, Squamous Cell of Head and Neck
European Organisation for Research and Treatment of Cancer - EORTC
 2017-11-16 PHASE2
NCT03983226 RECRUITING
Ovarian Cancer Recurrent; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
Shanghai Gynecologic Oncology Group
 2019-10-18 PHASE2
NCT04159155 TERMINATED
Endometrial Carcinoma; P53 Mutation; Serous Carcinoma
University Health Network, Toronto
 2020-11-17 PHASE2; PHASE3
NCT04544995 TERMINATED
Neoplasms
GlaxoSmithKline
 2020-10-06 PHASE1
NCT04861181 TERMINATED
Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer
Hospices Civils de Lyon
 2021-05-05 PHASE4
NCT04475939 COMPLETED
Lung Cancer, Non-Small Cell
GlaxoSmithKline
 2020-10-26 PHASE3
NCT04779151 TERMINATED
Urothelial Bladder Cancer; Gastric Adenocarcinoma; Gastro-oesophageal Adenocarcinoma; Head and Neck Cancer; Biliary Tract Cancer; Platinum-sensitive Urothelial Bladder Cancer; Clear Cell Renal Cell Carcinoma; Pancreatic Ductal Adenocarcinoma
Gustave Roussy, Cancer Campus, Grand Paris
 2021-04-07 PHASE2
NCT05455424 COMPLETED
Mesothelioma, Malignant
University Hospital Southampton NHS Foundation Trust
 2022-07-11 PHASE2
NCT05523440 TERMINATED
Recurrent Endometrial Carcinoma; Recurrent Ovarian Carcinoma; ARID1A Gene Mutation
University of Oklahoma
 2023-02-15 PHASE2
NCT04497844 ACTIVE_NOT_RECRUITING
Metastatic Castration-sensitive Prostate Cancer
Janssen Research & Development, LLC
 2020-09-23 PHASE3
NCT04679064 UNKNOWN
Ovarian Cancer
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2020-12-01 PHASE3
NCT04080284 COMPLETED
Endometrial Cancer; Papillary Serous Endometrial Carcinoma; Uterine Serous Carcinoma; Endometrial Carcinoma; Cancer of the Endometrium
Northwell Health
 2019-12-30 PHASE2
NCT05174455 WITHDRAWN
Locally Advanced Leiomyosarcoma; Metastatic Leiomyosarcoma; Stage III Retroperitoneal Sarcoma AJCC v8; Stage IIIA Retroperitoneal Sarcoma AJCC v8; Stage IIIB Retroperitoneal Sarcoma AJCC v8; Stage IV Retroperitoneal Sarcoma AJCC v8; Unresectable Leiomyosarcoma
David Liebner, MD
 2023-12-01 PHASE2
NCT05461690 UNKNOWN
Homologous Recombination Deficiency; Triple Negative Breast Cancer
Zhejiang Cancer Hospital
 2022-09-01 PHASE2
NCT04926324 TERMINATED
Rectal Neoplasms; Rectal Neoplasm Malignant
University of Iowa
 2022-07-07 PHASE1
NCT05126342 WITHDRAWN
Recurrent Ovarian Cancer; Recurrent Fallopian Tube Cancer; Primary Peritoneal Cancer
AGO Research GmbH
 2023-11-01 PHASE2
NCT03602859 ACTIVE_NOT_RECRUITING
Ovarian Neoplasms; Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Tesaro, Inc.
 2018-10-11 PHASE3
NCT04502602 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; Ovarian Cancer
Virginia Commonwealth University
 2020-08-24 PHASE1
NCT05232006 NOT_YET_RECRUITING
Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers
Assistance Publique - Hôpitaux de Paris
 2022-05 PHASE2
NCT03891576 TERMINATED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
Mario Negri Institute for Pharmacological Research
 2019-11-13 PHASE2
NCT05442749 TERMINATED
Metastatic Pancreatic Cancer
Centre Leon Berard
 2022-10-28 PHASE2
NCT05169437 TERMINATED
Solid Tumor; Breast Tumor; Colon Tumor, Malignant; Lung Tumor; Urologic Cancer; Pancreatic Cancer; Melanoma; Metastatic Cancer; Locally Advanced Solid Tumor; Esophageal Cancer; Endometrial Cancer; Head and Neck Cancer
Tempus AI
 2022-03-15 PHASE2
NCT03598270 COMPLETED
Recurrent Ovarian Carcinoma
Grupo Español de Investigación en Cáncer de Ovario
 2018-11-21 PHASE3
NCT04983745 UNKNOWN
Homologous Recombination Deficient Solid Tumors
West Cancer Center
 2021-11-29 PHASE2
NCT03425201 COMPLETED
Urothelial Cancer
Fundacion CRIS de Investigación para Vencer el Cáncer
 2019-10-14 PHASE1; PHASE2
NCT04037254 COMPLETED
Prostate Adenocarcinoma; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
NRG Oncology
 2019-10-08 PHASE1; PHASE2
NCT04940637 UNKNOWN
Lung Cancer; Mesothelioma
University of Turin, Italy
 2020-12-23 PHASE2
NCT03574779 COMPLETED
Ovarian Neoplasms
Tesaro, Inc.
 2018-11-15 PHASE2
NCT04915755 ACTIVE_NOT_RECRUITING
Neoplasms, Breast
GlaxoSmithKline
 2021-06-28 PHASE3
NCT06964165 TERMINATED
Ovarian Neoplasms
Tesaro, Inc.
 2022-04-14 PHASE2
NCT05162196 UNKNOWN
Recurrent Small Cell Lung Cancer
Wuhan University
 2022-06 PHASE2
NCT04149145 WITHDRAWN
Ovarian Cancer Recurrent
University of Alabama at Birmingham
 2023-05 PHASE1
NCT04826198 TERMINATED
Ovarian Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2020-10-05 PHASE1; PHASE2
NCT05076513 ACTIVE_NOT_RECRUITING
Glioblastoma; Glioblastoma Multiforme; Glioma; GBM; Glioma, Malignant; Glioblastoma Multiforme of Brain
Nader Sanai
 2021-10-29 EARLY_PHASE1
NCT05385068 UNKNOWN
Epithelial Ovarian Cancer
Peking Union Medical College Hospital
 2022-06 PHASE2
NCT04288687 COMPLETED
Prostate Adenocarcinoma
Abramson Cancer Center at Penn Medicine
 2020-10-19 PHASE2
NCT04185831 UNKNOWN
Solid Tumor
Uppsala University Hospital
 2020-10-20 PHASE2
NCT04030559 TERMINATED
ATM Gene Mutation; BRCA1 Gene Mutation; BRCA2 Gene Mutation; BRIP1 Gene Mutation; CDK12 Gene Mutation; CHEK1 Gene Mutation; CHEK2 Gene Mutation; DNA Damage Response Gene Mutation; DNA Repair Gene Mutation; FANCA Gene Mutation; FANCD2 Gene Mutation; FANCL Gene Mutation; GEN1 Gene Mutation; NBN Gene Mutation; Prostate Carcinoma; RAD51 Gene Mutation; RAD51C Gene Mutation
University of California, Davis
 2020-02-25 PHASE2
NCT04493060 COMPLETED
Metastatic Pancreatic Ductal Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8
Mayo Clinic
 2020-12-28 PHASE2
NCT04267939 TERMINATED
Advanced Solid Tumors (Excluding Prostate Cancer); Ovarian Cancer
Bayer
 2020-02-26 PHASE1
NCT05297864 TERMINATED
Recurrent Glioblastoma; Recurrent Astrocytoma; Recurrent Oligodendroglioma; Recurrent Glioma
University of Oklahoma
 2022-06-09 PHASE2
NCT03209401 TERMINATED
Solid Tumor, Adult; Homologous Recombination Deficiency
Georgetown University
 2017-10-13 PHASE1
NCT05666349 WITHDRAWN
Recurrent Glioblastoma
University College, London
 2023-10-13 PHASE1
NCT04481113 COMPLETED
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; HER2 Negative Breast Adenocarcinoma; Hormone Receptor Positive Breast Adenocarcinoma; Invasive Breast Carcinoma; Multifocal Breast Carcinoma; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Unilateral Breast Carcinoma
OHSU Knight Cancer Institute
 2021-06-07 PHASE1
NCT04284852 COMPLETED
Ovarian Cancer
The University of Hong Kong
 2020-05-01 PHASE2
NCT05641506 UNKNOWN
Ovarian Cancer
Sichuan Cancer Hospital and Research Institute
 2022-12 PHASE2
NCT04507841 ACTIVE_NOT_RECRUITING
Ovarian Cancer
Tongji Hospital
 2021-01-08 PHASE2
NCT05261269 COMPLETED
HER2-negative Metastatic Breast Cancer
Dantari, Inc.
 2022-02-02 PHASE1
NCT05412706 WITHDRAWN
Metastatic Colorectal Cancer
Ospedale Policlinico San Martino
 2023-09-04 PHASE2
NCT04655183 WITHDRAWN
Advanced Solid Tumor; Breast Cancer
EMD Serono Research & Development Institute, Inc.
 2020-12-01 PHASE1; PHASE2
NCT03783949 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
Universitaire Ziekenhuizen KU Leuven
 2018-11-30 PHASE2
NCT03695380 COMPLETED
OVARIAN CANCER
Hoffmann-La Roche
 2019-01-09 PHASE1
NCT05162872 UNKNOWN
Nasopharyngeal Carcinoma
Sun Yat-sen University
 2021-08-05 PHASE2
NCT04681469 RECRUITING
Head and Neck Squamous Cell Carcinoma
Gruppo Oncologico del Nord-Ovest
 2021-02-08 PHASE2
NCT03983993 ACTIVE_NOT_RECRUITING
Advanced Microsatellite Stable Colorectal Carcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Microsatellite Stable; RAS Wild Type; Stage IV Colorectal Cancer AJCC v8; MSI-H Colorectal Cancer
Emory University
 2019-10-15 PHASE2
NCT03553004 UNKNOWN
Pancreatic Cancer
University of Kansas Medical Center
 2019-01-22 PHASE2
NCT04235101 COMPLETED
Solid Tumor
Byondis B.V.
 2020-06-22 PHASE1
NCT04734665 UNKNOWN
Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor
Yonsei University
 2021-07-05 PHASE2
NCT05311579 UNKNOWN
Ovarian Carcinoma; Survival Outcomes; Adverse Events; Niraparib; Anlotinib; CA125; Chemotherapy; Targeted Therapy; Recurrent Ovarian Cancer
Lei Li
 2022-03-27 PHASE2
NCT03654833 COMPLETED
Mesothelioma, Malignant
University of Leicester
 2019-01-28 PHASE2
NCT05130515 COMPLETED
Platinum-resistant Recurrent Clear Cell Ovarian Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2021-12-15 PHASE2
NCT03221400 UNKNOWN
Carcinoma; Endometrial Adenocarcinoma; Neoplasms; Squamous Cell Carcinoma of the Anus; Adenocarcinoma of the Pancreas; Advanced Cancer; Solid Tumor; Solid Carcinoma; Squamous Cell Carcinoma of the Cervix; Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Vulva; Squamous Cell Carcinoma of the Penis; Gastric Cancer; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Small-cell Lung Cancer; Small Cell Lung Carcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Adenocarcinoma
Tarveda Therapeutics
 2017-08-29 PHASE1; PHASE2
NCT03759600 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
Takeda
 2018-12-26 PHASE2
NCT03806049 WITHDRAWN
Ovarian Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
 2019-12 PHASE3
NCT04240106 COMPLETED
Breast Cancer; Breast Cancer Metastatic
MedSIR
 2020-06-15 PHASE2
NCT03840967 TERMINATED
Esophageal Cancer; Gastric Cancer; Adenocarcinoma
Shadia Jalal, MD
 2019-07-09 PHASE2
NCT04895046 WITHDRAWN
HRD; Cholangiocarcinoma; Metastatic Cancer
Walid Shaib, MD
 2021-10-11 PHASE2
NCT04885413 UNKNOWN
Recurrent/ Advanced Stage Endometrial Cancer Patients
Sun Yat-sen University
 2021-07-01 PHASE2
NCT03207347 COMPLETED
Mesothelioma; Uveal Melanoma; Renal Cell Carcinoma; Cholangiocarcinoma
University of Florida
 2018-08-13 PHASE2
NCT04508803 COMPLETED
Treatment Efficacy
Fudan University
 2020-09-14 PHASE2
NCT02826512 TERMINATED
Breast Cancer
The Netherlands Cancer Institute
 2018-05-15 PHASE2
NCT03891615 UNKNOWN
Lung Cancer
Massachusetts General Hospital
 2019-06-06 PHASE1
NCT03644342 TERMINATED
Metastatic Carcinoma of the Cervix
Michelle S Ludwig
 2019-07-15 PHASE1; PHASE2
NCT03404960 COMPLETED
Pancreatic Adenocarcinoma
University of Pennsylvania
 2018-01-31 PHASE1; PHASE2
NCT05751629 COMPLETED
Ovarian Neoplasm
Tesaro, Inc.
 2018-11-15 PHASE2
NCT04395612 UNKNOWN
Cervical Cancer
Chongqing University Cancer Hospital
 2020-05-08 PHASE2
NCT04178460 TERMINATED
Gastric Cancer; Triple Negative Breast Cancer; Biliary Tract Carcinoma; Endometrial Carcinoma
Zai Lab (Shanghai) Co., Ltd.
 2020-02-03 PHASE1
NCT04556071 UNKNOWN
Ovarian Neoplasms; Fallopian Tube Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Ovarian Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Bevacizumab; Enzyme Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Angiogenesis; BRCA1 Mutation; BRCA2 Mutation; Homologous Recombination Deficiency
Xiaoxiang Chen
 2020-11-06 PHASE2
NCT04217798 UNKNOWN
Ovarian Cancer
Peking Union Medical College Hospital
 2020-05-21 PHASE2
NCT03925350 UNKNOWN
Metastatic Melanoma
California Pacific Medical Center Research Institute
 2019-03-20 PHASE2
NCT03709316 UNKNOWN
Ovarian Cancer
Zai Lab (Shanghai) Co., Ltd.
 2018-06-30 PHASE3
NCT04409002 COMPLETED
Pancreatic Cancer; Metastatic Pancreatic Cancer
Massachusetts General Hospital
 2020-07-23 PHASE2
NCT03944902 TERMINATED
Ovarian Cancer; Resistant BRCA Wild-Type Ovarian Cancer
University of Alabama at Birmingham
 2021-09-01 PHASE1
NCT04715620 UNKNOWN
Recurrent Glioblastoma
Tianjin Huanhu Hospital
 2021-01 PHASE2
NCT04376073 UNKNOWN
Platinum-resistant Ovarian Cancer
Jihong Liu
 2020-05-22 PHASE2
NCT03329001 COMPLETED
Neoplasms
Tesaro, Inc.
 2017-12-04 PHASE1
NCT04764084 UNKNOWN
HER2-negative Breast Cancer; Gastric Adenocarcinoma; Cholangiocarcinoma; Pancreatic Cancer
Peking University Cancer Hospital & Institute
 2021-04-01 PHASE1
NCT04577833 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Janssen Research & Development, LLC
 2020-11-13 PHASE1
NCT03748641 ACTIVE_NOT_RECRUITING
Castration-Resistant Prostatic Cancer
Janssen Research & Development, LLC
 2019-01-25 PHASE3
NCT03945084 COMPLETED
Urothelial Carcinoma
University of Turin, Italy
 2019-08-27 PHASE2
NCT03431350 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms, Castration-Resistant
Janssen Research & Development, LLC
 2018-03-02 PHASE2
NCT03955471 TERMINATED
Ovarian Neoplasms
Tesaro, Inc.
 2019-10-03 PHASE2
NCT03752216 COMPLETED
Ovarian Cancer
ARCAGY/ GINECO GROUP
 2019-04-03 PHASE4
NCT03154281 COMPLETED
Breast Cancer; Ovarian Cancer
Avera McKennan Hospital & University Health Center
 2017-07-26 PHASE1
NCT04392102 COMPLETED
Ovarian Cancer
Zai Lab (Shanghai) Co., Ltd.
 2020-08-04 PHASE2
NCT02854436 COMPLETED
Prostatic Neoplasms
Janssen Research & Development, LLC
 2016-08-31 PHASE2
NCT03016338 ACTIVE_NOT_RECRUITING
Endometrial Cancer
University Health Network, Toronto
 2017-11-06 PHASE2
NCT02044120 COMPLETED
Ewing Sarcoma
Sarcoma Alliance for Research through Collaboration
 2014-05 PHASE1
NCT03326193 COMPLETED
Ovarian Neoplasms
Tesaro, Inc.
 2017-12-12 PHASE2
NCT03308942 COMPLETED
Neoplasms
Tesaro, Inc.
 2017-09-29 PHASE2
NCT03307785 COMPLETED
Neoplasms; Metastatic Cancer; Advanced Cancer; Solid Tumor; Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer Stage IIIB; Non Small Cell Lung Cancer
Tesaro, Inc.
 2017-10-12 PHASE1
NCT03516084 TERMINATED
Extensive-stage Small Cell Lung Cancer
Zai Lab (Shanghai) Co., Ltd.
 2018-08-20 PHASE3
NCT03497429 COMPLETED
Advanced Solid Tumors
Takeda
 2018-04-05 PHASE1
NCT03705156 UNKNOWN
Platinum-sensitive Relapsed Ovarian Cancer
Zai Lab (Shanghai) Co., Ltd.
 2017-06-08 PHASE3
NCT03076203 COMPLETED
Prostate Carcinoma Metastatic to the Bone; Stage IV Prostate Adenocarcinoma; Hormone-refractory Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2017-09-22 PHASE1
NCT03329937 COMPLETED
Neoplasms, Breast
Tesaro, Inc.
 2018-04-12 PHASE1
NCT03895788 UNKNOWN
Ovarian Cancer
Hunan Cancer Hospital
 2019-01-14 PHASE1
NCT03359850 COMPLETED
Ovarian Neoplasms; Neoplasms; Solid Tumor; Hepatic Impairment
Tesaro, Inc.
 2018-02-20 PHASE1
NCT02924766 COMPLETED
Prostatic Neoplasms
Janssen Research & Development, LLC
 2016-10-03 PHASE1
NCT02655016 ACTIVE_NOT_RECRUITING
Ovarian Neoplasms
Tesaro, Inc.
 2016-07-11 PHASE3
NCT03759587 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
Takeda
 2018-12-28 PHASE2
NCT02354131 COMPLETED
Ovarian Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
 2015-02-15 PHASE1; PHASE2
NCT01905592 TERMINATED
Neoplasms, Breast; Carcinoma of Breast; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; BRCA1 Gene Mutation; BRCA2 Gene Mutation; Ovarian Neoplasms
Tesaro, Inc.
 2014-02-25 PHASE3
NCT02657889 COMPLETED
Neoplasms; Triple Negative Breast Cancer; Ovarian Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Stage IV Breast Cancer; Fallopian Tube Cancer; Peritoneal Cancer
Tesaro, Inc.
 2016-04-15 PHASE1; PHASE2
NCT03551171 COMPLETED
Ovarian Cancer
Zai Lab (Shanghai) Co., Ltd.
 2017-12-19 PHASE1
NCT02354586 COMPLETED
Ovarian Neoplasms; Ovarian Cancer
Tesaro, Inc.
 2015-03-23 PHASE2
NCT02500901 TERMINATED
Metastatic Prostate Cancer
Paul Mathew, MD
 2016-03 PHASE1
NCT01847274 COMPLETED
Ovarian Neoplasms; Platinum Sensitive Ovarian Cancer
Tesaro, Inc.
 2013-06-21 PHASE3
NCT02476552 COMPLETED
Cancer
Tesaro, Inc.
 2015-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-04)

Check the Niraparib tosylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Niraparib tosylate selectively binds to and inhibits poly(ADP-ribose) polymerase 1 and 2 (PARP1/2), trapping PARP enzymes on damaged DNA and preventing effective single-strand break repair. This accumulation of PARP-DNA complexes induces lethal double-strand DNA breaks and triggers apoptotic cell death, which provides therapeutic synthetic lethality in homologous recombination-deficient tumors such as ovarian, breast, and prostate cancers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.