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 cancer. Niraparib was approved by the European Commission on November 16, 2017 and by Health Canada on June 27, 2019.
- 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.
In Canada and the US, niraparib is also available in a combination product with abiraterone, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.
- 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
The Drug Rediscovery Protocol (DRUP Trial)
- Conditions
- CancerTumorsNeoplasmNeoplasia
- Interventions
- First Posted Date
- 2016-10-05
- Last Posted Date
- 2024-01-24
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 1550
- Registration Number
- NCT02925234
- Locations
- 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱Amsterdam UMC, locatie AMC, Amsterdam, Netherlands
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
- First Posted Date
- 2016-08-03
- Last Posted Date
- 2025-03-04
- 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
- 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
- Conditions
- Triple Negative Breast CancerBreast CancerMetastatic Breast CancerNeoplasmsAdvanced Breast CancerOvarian CancerStage IV Breast CancerFallopian Tube CancerPeritoneal Cancer
- Interventions
- Biological: pembrolizumab
- 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
- 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)
- 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
Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer
- Conditions
- Cancer
- Interventions
- First Posted Date
- 2015-06-19
- Last Posted Date
- 2020-01-13
- Lead Sponsor
- Tesaro, Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT02476552
- Locations
- 🇳🇱
The Netherlands Cancer Institute, Amsterdam, Netherlands
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
- 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
Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer
- 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
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
- Conditions
- Ewing Sarcoma
- Interventions
- First Posted Date
- 2014-01-23
- Last Posted Date
- 2021-01-12
- 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
Drug Development Updates
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