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

Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

First Posted Date
2018-07-26
Last Posted Date
2024-01-02
Lead Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Target Recruit Count
414
Registration Number
NCT03598270
Locations
🇧🇪

Grand Hôpital de Charleroi, Charleroi, Belgium

🇪🇸

Clinica Universidad de Navarra, Pamplona, Navarra, Spain

🇮🇹

Istituto Europeo di Oncologia, Milano, Italy

and more 68 locations

Niraparib in Patients With Pancreatic Cancer

Phase 2
Active, not recruiting
Conditions
Pancreatic Cancer
Interventions
Drug: Niraparib
First Posted Date
2018-07-26
Last Posted Date
2024-10-22
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
32
Registration Number
NCT03601923
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

First Posted Date
2018-07-13
Last Posted Date
2024-06-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
31
Registration Number
NCT03586661
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

First Posted Date
2018-07-02
Last Posted Date
2024-08-12
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
125
Registration Number
NCT03574779
Locations
🇹🇷

GSK Investigational Site, Antalya, Turkey

A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors

Phase 1
Completed
Conditions
Advanced Solid Tumors
Interventions
Drug: Niraparib
First Posted Date
2018-04-13
Last Posted Date
2021-11-09
Lead Sponsor
Takeda
Target Recruit Count
9
Registration Number
NCT03497429
Locations
🇯🇵

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

First Posted Date
2017-12-11
Last Posted Date
2024-01-02
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
40
Registration Number
NCT03368729
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Montefiore, Bronx, New York, United States

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 4 locations

Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients

First Posted Date
2017-12-02
Last Posted Date
2021-05-28
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
17
Registration Number
NCT03359850
Locations
🇺🇸

GSK Investigational Site, Houston, Texas, United States

Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer

Phase 1
Completed
Conditions
Neoplasms, Breast
Interventions
Drug: Niraparib
First Posted Date
2017-11-06
Last Posted Date
2021-01-12
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
21
Registration Number
NCT03329937
Locations
🇺🇸

GSK Investigational Site, Nashville, Tennessee, United States

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

Phase 2
Active, not recruiting
Conditions
Ovarian Neoplasms
Interventions
Drug: Niraparib
Biological: Bevacizumab
First Posted Date
2017-10-31
Last Posted Date
2023-03-07
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
105
Registration Number
NCT03326193
Locations
🇺🇸

GSK Investigational Site, Seattle, Washington, United States

Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

First Posted Date
2017-10-13
Last Posted Date
2023-10-16
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
53
Registration Number
NCT03308942
Locations
🇺🇸

GSK Investigational Site, Tacoma, Washington, United States

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