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

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Phase 1

Active, not recruiting

Conditions: Advanced Cancer
Non Small Cell Lung Cancer Stage IIIB
Neoplasms
Solid Tumor
Non Small Cell Lung Cancer Metastatic
Non Small Cell Lung Cancer
Metastatic Cancer

Interventions: Drug: Niraparib
Drug: TSR-042
Drug: Carboplatin-Paclitaxel
Drug: Carboplatin-Pemetrexed
Drug: TSR-022
Drug: Bevacizumab
Drug: Carboplatin-Nab-Paclitaxel

First Posted Date: 2017-10-12

Last Posted Date: 2024-05-29

Lead Sponsor: Tesaro, Inc.

Target Recruit Count: 58

Registration Number: NCT03307785

Locations: 🇺🇸
GSK Investigational Site, San Marcos, Texas, United States

PEN-866 in Patients With Advanced Solid Malignancies

Phase 1

Conditions: Adenocarcinoma of the Pancreas
Gastroesophageal Junction Adenocarcinoma
Small Cell Lung Carcinoma
Solid Tumor
Solid Carcinoma
Small-cell Lung Cancer
Squamous Cell Carcinoma of the Vulva
Gastric Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Adenocarcinoma

Interventions: Drug: PEN-866 Sodium
Drug: Niraparib
Drug: fluorouracil
Drug: Folinic acid

First Posted Date: 2017-07-18

Last Posted Date: 2022-02-17

Lead Sponsor: Tarveda Therapeutics

Target Recruit Count: 340

Registration Number: NCT03221400

Locations: 🇺🇸
Florida Cancer Specialists - North, Saint Petersburg, Florida, United States
🇺🇸
Florida Cancer Specialists - South, Fort Myers, Florida, United States
🇺🇸
Florida Cancer Specialists - East, West Palm Beach, Florida, United States

and more 13 locations

Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies

Phase 1

Terminated

Conditions: Solid Tumor, Adult
Homologous Recombination Deficiency

Interventions: Drug: Niraparib
Drug: Carboplatin

First Posted Date: 2017-07-06

Last Posted Date: 2024-02-05

Lead Sponsor: Georgetown University

Target Recruit Count: 23

Registration Number: NCT03209401

Locations: 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 2 locations

A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

Phase 2

Completed

Conditions: Renal Cell Carcinoma
Mesothelioma
Uveal Melanoma
Cholangiocarcinoma

Interventions: Drug: Niraparib

First Posted Date: 2017-07-02

Last Posted Date: 2023-09-15

Lead Sponsor: University of Florida

Target Recruit Count: 37

Registration Number: NCT03207347

Locations: 🇺🇸
University of Florida, Gainesville, Florida, United States
🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
Orlando Health UF Health Cancer Center, Orlando, Florida, United States

Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast

Phase 1

Completed

Conditions: Breast Cancer
Ovarian Cancer

Interventions: Drug: niraparib
Drug: everolimus

First Posted Date: 2017-05-16

Last Posted Date: 2024-08-01

Lead Sponsor: Avera McKennan Hospital & University Health Center

Target Recruit Count: 14

Registration Number: NCT03154281

Locations: 🇺🇸
Avera Cancer Institute, Sioux Falls, South Dakota, United States

Biomarker-based Study in R/M SCCHN

Phase 2

Active, not recruiting

Conditions: Carcinoma, Squamous Cell of Head and Neck

Interventions: Drug: Niraparib
Drug: INCAGN01876
Drug: IPH2201
Drug: Afatinib
Drug: Palbociclib
Drug: standard of care
Drug: Durvalumab

First Posted Date: 2017-03-23

Last Posted Date: 2023-11-03

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 340

Registration Number: NCT03088059

Locations: 🇧🇪
CHU Saint-Pierre-Site Porte de Hal, Brussels, Belgium
🇮🇹
IRCCS - Fondazione G. Pascale, Napoli, Italy
🇬🇧
Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, United Kingdom

and more 30 locations

Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)

Phase 1

Completed

Conditions: Prostate Carcinoma Metastatic to the Bone
Stage IV Prostate Adenocarcinoma
Hormone-refractory Prostate Cancer

Interventions: Drug: Niraparib
Radiation: Radium Ra 223 Dichloride

First Posted Date: 2017-03-10

Last Posted Date: 2025-04-29

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 14

Registration Number: NCT03076203

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
🇺🇸
Tulane University, New Orleans, Louisiana, United States

and more 3 locations

Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Conditions: Recurrent Ovarian Cancer

First Posted Date: 2017-01-20

Last Posted Date: 2017-04-17

Lead Sponsor: Tesaro, Inc.

Registration Number: NCT03025867

Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Endometrial Cancer

Interventions: Drug: Niraparib
Drug: TSR-042

First Posted Date: 2017-01-10

Last Posted Date: 2024-01-30

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 51

Registration Number: NCT03016338

Locations: 🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada
🇨🇦
London Regional Cancer Centre, London, Ontario, Canada
🇨🇦
Juravinski Cancer Centre, Hamilton, Ontario, Canada

and more 4 locations

A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)

Phase 1

Completed

Conditions: Prostatic Neoplasms

Interventions: Drug: Niraparib
Drug: Apalutamide
Drug: Abiraterone Acetate
Drug: Prednisone

First Posted Date: 2016-10-05

Last Posted Date: 2020-07-20

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 34

Registration Number: NCT02924766

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