Niraparib

Generic Name: Niraparib

Brand Names: Zejula

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₀N_₄O

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

Clinical Trials

Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects

Phase 2

Recruiting

Conditions: ATM Gene Mutation
BRCA1 Gene Mutation
DNA Damage Response Gene Mutation
DNA Repair Gene Mutation
BRCA2 Gene Mutation
FANCA Gene Mutation
FANCD2 Gene Mutation
FANCL Gene Mutation
GEN1 Gene Mutation
NBN Gene Mutation

Interventions: Drug: Niraparib
Drug: Niraparib Tosylate Monohydrate
Procedure: Radical Prostatectomy

First Posted Date: 2019-07-24

Last Posted Date: 2025-01-07

Lead Sponsor: Marc Dall'Era, MD

Target Recruit Count: 30

Registration Number: NCT04030559

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Advanced Microsatellite Stable Colorectal Carcinoma
RAS Wild Type
Microsatellite Stable
MSI-H Colorectal Cancer
Metastatic Microsatellite Stable Colorectal Carcinoma
Stage IV Colorectal Cancer AJCC v8

Interventions: Drug: Niraparib
Biological: Panitumumab

First Posted Date: 2019-06-12

Last Posted Date: 2025-04-09

Lead Sponsor: Emory University

Target Recruit Count: 26

Registration Number: NCT03983993

Locations: 🇺🇸
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

Phase 2

Recruiting

Conditions: Ovarian Cancer Recurrent
Primary Peritoneal Carcinoma
Fallopian Tube Cancer

Interventions: Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Procedure: Surgery
Drug: Niraparib

First Posted Date: 2019-06-12

Last Posted Date: 2022-03-18

Lead Sponsor: Shanghai Gynecologic Oncology Group

Target Recruit Count: 167

Registration Number: NCT03983226

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, China
🇨🇳
Zhejiang Cancer Hospital, Hangzhou, China
🇨🇳
Fudan University Shanghai Zhongshan Hospital, Shanghai, Shanghai, China

and more 2 locations

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Phase 3

Active, not recruiting

Conditions: Neoplasms

Interventions: Biological: Dostarlimab
Drug: Placebo matching dostarlimab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Placebo matching Niraparib
Drug: Niraparib

First Posted Date: 2019-06-11

Last Posted Date: 2024-11-27

Lead Sponsor: Tesaro, Inc.

Target Recruit Count: 785

Registration Number: NCT03981796

Locations: 🇬🇧
GSK Investigational Site, Truro, United Kingdom

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

Phase 2

Terminated

Conditions: Ovarian Neoplasms

Interventions: Drug: Niraparib
Drug: Dostarlimab

First Posted Date: 2019-05-20

Last Posted Date: 2022-09-10

Lead Sponsor: Tesaro, Inc.

Target Recruit Count: 41

Registration Number: NCT03955471

Locations: 🇺🇸
GSK Investigational Site, Charlottesville, Virginia, United States

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

Phase 1

Active, not recruiting

Conditions: Triple Negative Breast Cancer
Residual Disease

Interventions: Drug: Niraparib
Radiation: Radiation Therapy

First Posted Date: 2019-05-10

Last Posted Date: 2025-02-27

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 20

Registration Number: NCT03945721

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, United States

Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

Phase 2

Completed

Conditions: Urothelial Carcinoma

Interventions: Drug: Niraparib
Other: Best supportive care

First Posted Date: 2019-05-10

Last Posted Date: 2022-05-23

Lead Sponsor: University of Turin, Italy

Target Recruit Count: 58

Registration Number: NCT03945084

Locations: 🇮🇹
Azienda Sanitaria Locale CN2 - Alba e Bra, Alba, Italy
🇮🇹
Azienda USL Toscana Sud Est, Ospedale San Donato, Arezzo, Italy
🇮🇹
Istituto Tumori Giovanni Paolo II - IRCCS, Bari, Italy

and more 17 locations