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

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Phase 3

Active, not recruiting

Conditions: Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Ovarian Neoplasms

Interventions: Drug: Standard of care
Drug: Niraparib
Drug: Dostarlimab (TSR-042)
Drug: Dostarlimab-Placebo
Drug: Niraparib-Placebo

First Posted Date: 2018-07-27

Last Posted Date: 2024-08-16

Lead Sponsor: Tesaro, Inc.

Target Recruit Count: 1402

Registration Number: NCT03602859

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

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

Phase 3

Active, not recruiting

Conditions: Recurrent Ovarian Carcinoma

Interventions: Drug: Placebo
Drug: Carboplatin
Drug: Paclitaxel
Drug: Niraparib
Drug: Pegylated liposomal doxorubicin (PLD)
Drug: Gemcitabine
Drug: Atezolizumab

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

Phase 1

Active, not recruiting

Conditions: Deleterious BRCA1 Gene Mutation
Deleterious BRCA2 Gene Mutation
Endometrial Adenocarcinoma
Primary Peritoneal High Grade Serous Adenocarcinoma
Recurrent Endometrial Carcinoma
High Grade Ovarian Serous Adenocarcinoma
Progressive Disease
Platinum-Resistant Ovarian Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma

Interventions: Drug: Copanlisib
Drug: Niraparib

First Posted Date: 2018-07-13

Last Posted Date: 2025-01-09

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

Phase 2

Active, not recruiting

Conditions: Ovarian Neoplasms

Interventions: Drug: Niraparib
Biological: TSR-042
Biological: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel

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

Phase 1

Recruiting

Conditions: Metastatic Breast Cancer
HER2 Positive Breast Carcinoma

Interventions: Drug: Niraparib
Drug: Trastuzumab

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