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

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

Phase 3

Active, not recruiting

Conditions: Neoplasms, Breast

Interventions: Drug: Niraparib
Drug: Placebo

First Posted Date: 2021-06-07

Last Posted Date: 2024-07-22

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 43

Registration Number: NCT04915755

Locations: 🇬🇧
GSK Investigational Site, Wigan., United Kingdom

Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Phase 2

Withdrawn

Conditions: Cholangiocarcinoma
HRD
Metastatic Cancer

Interventions: Drug: Niraparib
Drug: Dostarlimab

First Posted Date: 2021-05-20

Last Posted Date: 2022-06-29

Lead Sponsor: Walid Shaib, MD

Registration Number: NCT04895046

An Open-label, Single Arm, Phase II Trial of Niraparib in Combination With Anti-PD1（Programmed Cell Death Protein 1） Antibody in Recurrent/ Advanced Stage Endometrial Cancer Patients

Phase 2

Conditions: Recurrent/ Advanced Stage Endometrial Cancer Patients

Interventions: Drug: Niraparib in Combination With Anti-PD1 Antibody

First Posted Date: 2021-05-13

Last Posted Date: 2021-08-23

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 37

Registration Number: NCT04885413

Locations: 🇨🇳
Sun Yat-sen University Cancer Centre, Guangzhou, Guangdong, China

Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Niraparib
Drug: Dostarlimab
Radiation: Radiation therapy

First Posted Date: 2021-04-08

Last Posted Date: 2023-11-15

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 32

Registration Number: NCT04837209

Locations: 🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months

Phase 1

Terminated

Conditions: Ovarian Cancer

Interventions: Drug: AsiDNA
Drug: Niraparib
Drug: Olaparib
Drug: Rucaparib

First Posted Date: 2021-04-01

Last Posted Date: 2024-12-05

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 13

Registration Number: NCT04826198

Locations: 🇫🇷
CHU Jean Minjoz, Besançon, Besancon, France
🇫🇷
Hospices civils de Lyon(CHU Lyon Sud), Pierre-Bénite, Lyon, France
🇫🇷
Institut de Cancérologie de l'Ouest - St Herblain, Saint-Herblain, Nantes, France

and more 3 locations

Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

Phase 2

Recruiting

Conditions: Prostate Cancer

Interventions: Drug: Abiraterone Acetate 250mg
Drug: Apalutamide 60mg Tab
Drug: Atezolizumab
Drug: Prednisone 5mg Tab
Drug: Niraparib 100mg Oral Capsule
Drug: Docetaxel

First Posted Date: 2021-03-23

Last Posted Date: 2024-12-16

Lead Sponsor: University of British Columbia

Target Recruit Count: 315

Registration Number: NCT04812366

Locations: 🇺🇸
University of California Davis, Sacramento, California, United States
🇺🇸
Brigham & Women's Hospital, Boston, Massachusetts, United States
🇺🇸
University of Michigan Health, Ann Arbor, Michigan, United States

and more 6 locations

Real-life Use of Niraparib in a Patient Access Program in Norway

Completed

Conditions: Peritoneal Cancer
Ovarian Cancer

First Posted Date: 2021-03-08

Last Posted Date: 2021-03-08

Lead Sponsor: Kristina Lindemann

Target Recruit Count: 106

Registration Number: NCT04785716

Locations: 🇳🇴
Oslo University Hospital (OUH), Oslo, Norway

Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

Phase 2

Suspended

Conditions: Biliary Tract Cancer
Gastro-oesophageal Adenocarcinoma
Head and Neck Cancer
Urothelial Bladder Cancer
Clear Cell Renal Cell Carcinoma
Gastric Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Platinum-sensitive Urothelial Bladder Cancer