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
Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
- Conditions
- Platinum-Resistant Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaRecurrent Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaRecurrent Primary Peritoneal Carcinoma
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionOther: Questionnaire AdministrationDietary Supplement: Selenium
- First Posted Date
- 2023-01-05
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 45
- Registration Number
- NCT05672095
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Reirradiation and Niraparib in Patients With Recurrent Glioblastoma
- Conditions
- Recurrent Glioblastoma
- Interventions
- Radiation: Re-irradiation (re-RT)
- First Posted Date
- 2022-12-27
- Last Posted Date
- 2024-03-26
- Lead Sponsor
- University College, London
- Registration Number
- NCT05666349
A Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Nausea of Niraparib in the Maintenance Treatment in Ovarian Cancer
- First Posted Date
- 2022-12-07
- Last Posted Date
- 2022-12-07
- Lead Sponsor
- Sichuan Cancer Hospital and Research Institute
- Target Recruit Count
- 50
- Registration Number
- NCT05641506
- Locations
- 🇨🇳
Sicchuan cancer hospital, Chengdu, Sichuan, China
Personalized Medicine for Advanced Biliary Cancer Patients
- Conditions
- Biliary Tract Neoplasms
- Interventions
- First Posted Date
- 2022-11-14
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 800
- Registration Number
- NCT05615818
- Locations
- 🇫🇷
APHP - Hôpital Paul Brousse, Villejuif, France
🇫🇷Gustave Roussy, Villejuif, France
🇫🇷APHP - Hôpital Cochin, Paris, France
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2022-11-01
- Last Posted Date
- 2025-01-14
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 484
- Registration Number
- NCT05601440
- Locations
- 🇨🇦
Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇨🇦Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
🇨🇦Odette Cancer Centre, Toronto, Ontario, Canada
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
- First Posted Date
- 2022-09-02
- Last Posted Date
- 2025-05-09
- Target Recruit Count
- 25
- Registration Number
- NCT05526989
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Moffitt Cancer Center, Tampa, Florida, United States
Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation
- Conditions
- Recurrent Endometrial CarcinomaRecurrent Ovarian CarcinomaARID1A Gene Mutation
- Interventions
- First Posted Date
- 2022-08-31
- Last Posted Date
- 2025-03-28
- Lead Sponsor
- University of Oklahoma
- Target Recruit Count
- 7
- Registration Number
- NCT05523440
- Locations
- 🇺🇸
University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
🇺🇸University of Virginia Comprehensive Cancer Center, Charlottesville, Virginia, United States
A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr
- First Posted Date
- 2022-08-29
- Last Posted Date
- 2022-08-29
- Lead Sponsor
- Institut Paoli-Calmettes
- Target Recruit Count
- 72
- Registration Number
- NCT05519670
A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA
- Conditions
- Sarcoma,Soft TissueSarcoma Uterus
- Interventions
- First Posted Date
- 2022-08-25
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 8
- Registration Number
- NCT05515575
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States
Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency
- Conditions
- Triple Negative Breast CancerHomologous Recombination Deficiency
- Interventions
- First Posted Date
- 2022-07-18
- Last Posted Date
- 2022-07-18
- Lead Sponsor
- Zhejiang Cancer Hospital
- Target Recruit Count
- 50
- Registration Number
- NCT05461690
Drug Development Updates
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