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 Combined With Radiotherapy in rGBM

Phase 2

Conditions: Recurrent Glioblastoma

Interventions: Drug: Niraparib

First Posted Date: 2021-01-20

Last Posted Date: 2021-01-20

Lead Sponsor: Tianjin Huanhu Hospital

Target Recruit Count: 30

Registration Number: NCT04715620

Locations: 🇨🇳
Tianjin Huanhu Hosptal, Tianjin, Tianjin, China

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

Phase 2

Recruiting

Conditions: Serous Carcinoma
Endometrial Carcinoma

Interventions: Drug: Niraparib

First Posted Date: 2021-01-20

Last Posted Date: 2024-01-05

Lead Sponsor: Shandong University

Target Recruit Count: 83

Registration Number: NCT04716686

Locations: 🇨🇳
Qilu Hospital of Shandong University, Jinan, Shandong, China

Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas

Phase 2

Active, not recruiting

Conditions: Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Neuroendocrine Carcinoma
Lung Small Cell Carcinoma

Interventions: Biological: Dostarlimab
Drug: Niraparib

First Posted Date: 2021-01-08

Last Posted Date: 2025-05-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 48

Registration Number: NCT04701307

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Niraparib

First Posted Date: 2020-12-23

Last Posted Date: 2022-08-04

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 49

Registration Number: NCT04681469

Locations: 🇮🇹
Asst Degli Spedali Civili Di Brescia, Brescia, Italy

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Phase 3

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Pegylated liposomal doxorubicin
Drug: Niraparib
Drug: Paclitaxel
Drug: Dostarlimab
Drug: Gemcitabine
Drug: Topotecan
Drug: Bevacizumab

First Posted Date: 2020-12-22

Last Posted Date: 2021-08-27

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 427

Registration Number: NCT04679064

Locations: 🇮🇹
Istituto Tumori della Romagna IRST IRCCS, Meldola, Italy
🇮🇹
Azienda Ospedaliera Spedali Civili, Brescia, Italy
🇮🇹
IEO-Istituto Europeo di Oncologia, Milan, Italy

and more 5 locations

Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer

Phase 1

Active, not recruiting

Conditions: Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
BRCA-Associated Malignant Neoplasm
BRCA Hereditary Ovarian Carcinoma
Metastatic BRCA Hereditary Breast Carcinoma
Metastatic Breast Carcinoma
Metastatic Fallopian Tube Carcinoma
Metastatic Malignant Solid Neoplasm
Metastatic Ovarian Carcinoma
Metastatic Pancreatic Carcinoma

Interventions: Biological: Dostarlimab
Drug: Niraparib
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging

First Posted Date: 2020-12-17

Last Posted Date: 2025-04-15

Lead Sponsor: University of Washington

Target Recruit Count: 18

Registration Number: NCT04673448

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Study of M4344 in Combination With Niraparib

Phase 1

Withdrawn

Conditions: Advanced Solid Tumor
Breast Cancer

Interventions: Drug: Niraparib
Drug: M4344

First Posted Date: 2020-12-07

Last Posted Date: 2021-06-30

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Registration Number: NCT04655183

A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Phase 2

Active, not recruiting

Conditions: Ovarian Neoplasms
Breast Neoplasms

Interventions: Drug: Niraparib

First Posted Date: 2020-11-23

Last Posted Date: 2025-03-10

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 26

Registration Number: NCT04641247

Locations: 🇪🇸
GSK Investigational Site, Madrid, Spain

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Metastatic Prostate Neuroendocrine Carcinoma
Aggressive Variant Prostate Carcinoma
Metastatic Prostate Small Cell Carcinoma

Interventions: Drug: Cabazitaxel
Drug: Carboplatin
Biological: Cetrelimab
Drug: Niraparib

First Posted Date: 2020-10-19

Last Posted Date: 2025-01-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 120

Registration Number: NCT04592237

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Phase 2

Active, not recruiting

Conditions: Germline BRCA2 Gene Mutation
Germline BRCA1 Gene Mutation
Deleterious PALB2 Gene Mutation
Stage I Breast Cancer
Stage II Breast Cancer
Breast Cancer
HER2-negative Breast Cancer
Stage III Breast Cancer

Interventions: Drug: Niraparib
Drug: Dostarlimab

First Posted Date: 2020-10-12

Last Posted Date: 2025-04-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 62

Registration Number: NCT04584255

Locations: 🇺🇸
Yale University Cancer Center, New Haven, Connecticut, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 5 locations

Drug Development Updates

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