Niraparib

Generic Name
Niraparib
Brand Names
Zejula
Drug Type
Small Molecule
Chemical Formula
C19H20N4O
CAS Number
1038915-60-4
Unique Ingredient Identifier
HMC2H89N35
Background

Niraparib is an orally active poly (ADP-ribose) polymerase (PARP) inhibitor. By blocking the enzymes responsible for DNA repair, niraparib induces cytotoxicity in cancer cells. Niraparib is selective towards PARP-1 and PARP-2. First approved by the FDA on March 27, 2017, niraparib is used to treat epithelial ovarian, fallopian tube, or primary peritoneal can...

Indication

Niraparib is indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
...

Associated Conditions
Advanced Epithelial Ovarian Cancer, Advanced Primary Peritoneal Carcinoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Recurrent Epithelial Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Advanced Fallopian Tubes Cancer
Associated Therapies
Maintenance therapy
Clinical Trials
Related News

A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

First Posted Date
2016-10-05
Last Posted Date
2020-07-20
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
34
Registration Number
NCT02924766

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Phase 2
Completed
Conditions
Prostatic Neoplasms
Interventions
Drug: Niraparib
First Posted Date
2016-08-03
Last Posted Date
2023-11-13
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
289
Registration Number
NCT02854436

A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
Drug: Niraparib
First Posted Date
2016-07-11
Last Posted Date
2022-07-18
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
9
Registration Number
NCT02826512
Locations
🇳🇱

Deventer ziekenhuis, Deventer, Netherlands

🇳🇱

Antoni van Leeuwenhoek, Amsterdam, Netherlands

🇳🇱

Erasmus Medical Center Cancer Institute, Rotterdam, Netherlands

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

First Posted Date
2016-01-18
Last Posted Date
2022-12-01
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
122
Registration Number
NCT02657889
Locations
🇺🇸

GSK Investigational Site, Seattle, Washington, United States

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Phase 3
Active, not recruiting
Conditions
Ovarian Neoplasms
Interventions
Drug: Niraparib
Drug: Placebo
First Posted Date
2016-01-13
Last Posted Date
2024-10-02
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
733
Registration Number
NCT02655016
Locations
🇬🇧

GSK Investigational Site, Truro, United Kingdom

Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)

Phase 1
Terminated
Conditions
Metastatic Prostate Cancer
Interventions
Drug: Enzalutamide
Drug: Niraparib
First Posted Date
2015-07-17
Last Posted Date
2019-10-21
Lead Sponsor
Paul Mathew, MD
Target Recruit Count
2
Registration Number
NCT02500901
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer

Phase 1
Completed
Conditions
Ovarian Cancer
Interventions
Drug: Niraparib
Drug: Bevacizumab
First Posted Date
2015-02-03
Last Posted Date
2022-08-30
Lead Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Target Recruit Count
108
Registration Number
NCT02354131
Locations
🇩🇰

Rigshospitalet, Copenhagen, Sjaelland, Denmark

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

Phase 2
Completed
Conditions
Ovarian Neoplasms
Ovarian Cancer
Interventions
Drug: Niraparib
First Posted Date
2015-02-03
Last Posted Date
2022-09-15
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
463
Registration Number
NCT02354586
Locations
🇨🇦

GSK Investigational Site, Sherbrooke, Quebec, Canada

ESP1/SARC025 Global Collaboration: A Phase I Study of a Combination of the PARP Inhibitor, Niraparib and Temozolomide and/or Irinotecan Patients With Previously Treated, Incurable Ewing Sarcoma

First Posted Date
2014-01-23
Last Posted Date
2021-01-12
Lead Sponsor
Sarcoma Alliance for Research through Collaboration
Target Recruit Count
34
Registration Number
NCT02044120
Locations
🇺🇸

Children's Hospital of Los Angeles, Los Angeles, California, United States

🇺🇸

Seattle's Children Cancer Center, Seattle, Washington, United States

🇬🇧

University College London Hospital, London, United Kingdom

and more 2 locations

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

First Posted Date
2013-07-23
Last Posted Date
2022-11-15
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
216
Registration Number
NCT01905592
Locations
🇬🇧

GSK Investigational Site, Whitchurch, Cardiff, United Kingdom

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