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

SMMART Adaptive Clinical Treatment (ACT) Trial

Early Phase 1

Withdrawn

Conditions: Advanced Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Advanced Prostate Carcinoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Breast Carcinoma
Stage IV Ovarian Cancer AJCC v8
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma

Interventions: Drug: Alectinib
Drug: Alpelisib
Drug: Anastrozole
Biological: Atezolizumab
Biological: Bevacizumab
Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Capecitabine
Drug: Carboplatin
Drug: Cobimetinib
Drug: Entrectinib
Drug: Eribulin
Drug: Fulvestrant
Biological: Hyaluronidase-zzxf/Pertuzumab/Trastuzumab
Drug: Irinotecan
Drug: Letrozole
Drug: Nab-paclitaxel
Drug: Niraparib
Drug: Olaparib
Drug: Paclitaxel
Drug: Palbociclib
Biological: Pertuzumab
Other: Quality-of-Life Assessment
Biological: Trastuzumab
Biological: Trastuzumab Emtansine
Drug: Vemurafenib
Drug: Vinorelbine
Drug: Vismodegib

First Posted Date: 2022-02-14

Last Posted Date: 2024-01-23

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT05238831

PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

Phase 2

Not yet recruiting

Conditions: Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

Interventions: Drug: Niraparib

First Posted Date: 2022-02-09

Last Posted Date: 2022-03-08

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 12

Registration Number: NCT05232006

A Study of ZN-c3 and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

Phase 1

Active, not recruiting

Conditions: Primary Peritoneal Carcinoma
Ovarian Cancer
Platinum-resistant Ovarian Cancer
Fallopian Tube Cancer

Interventions: Drug: ZN-c3
Drug: Niraparib

First Posted Date: 2022-01-20

Last Posted Date: 2024-06-24

Lead Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Target Recruit Count: 117

Registration Number: NCT05198804

Locations: 🇺🇸
Rutgers New Jersey Medical School, Newark, New Jersey, United States
🇺🇸
Virginia Cancer Specialists, Fairfax, Virginia, United States
🇺🇸
Arizona Oncology Associates (Wilmot HOPE) - USOR, Tucson, Arizona, United States

and more 17 locations

Niraparib with BeVAcizumab After Complete CytoreductioN in Patients with OvArian Cancer

Phase 2

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Chemotherapy
Drug: Niraparib
Drug: Bevacizumab-Awwb

First Posted Date: 2022-01-11

Last Posted Date: 2024-10-16

Lead Sponsor: ARCAGY/ GINECO GROUP

Target Recruit Count: 390

Registration Number: NCT05183984

Locations: 🇫🇷
Clinique Victor Hugo, Le Mans, France
🇫🇷
CHU Montpellier - Hôpital Saint Eloi, Montpellier, France
🇫🇷
Hôpital Saint-Joseph, Paris, France

and more 84 locations

PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

Phase 4

Not yet recruiting

Conditions: Ovarian Cancer Stage III
Ovarian Cancer Stage IV
Epithelial Ovarian Cancer
Ovarian Cancer

Interventions: Drug: Niraparib

First Posted Date: 2022-01-11

Last Posted Date: 2022-01-26

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 102

Registration Number: NCT05187208

Niraparib for the Treatment of Leiomyosarcoma

Phase 2

Withdrawn

Conditions: Locally Advanced Leiomyosarcoma
Unresectable Leiomyosarcoma
Stage IIIA Retroperitoneal Sarcoma AJCC v8
Stage III Retroperitoneal Sarcoma AJCC v8
Stage IV Retroperitoneal Sarcoma AJCC v8
Metastatic Leiomyosarcoma
Stage IIIB Retroperitoneal Sarcoma AJCC v8

Interventions: Drug: Niraparib Tosylate Monohydrate

First Posted Date: 2021-12-30

Last Posted Date: 2023-09-18

Lead Sponsor: David Liebner, MD

Registration Number: NCT05174455

Niraparib in the Treatment of Patients with Advanced PALB2 Mutated Tumors

Phase 2

Terminated

Conditions: Solid Tumor
Breast Tumor
Colon Tumor, Malignant
Urologic Cancer
Melanoma
Metastatic Cancer
Lung Tumor
Head and Neck Cancer
Pancreatic Cancer
Esophageal Cancer

Interventions: Drug: Niraparib

First Posted Date: 2021-12-27

Last Posted Date: 2024-09-30

Lead Sponsor: Tempus AI

Target Recruit Count: 22

Registration Number: NCT05169437

Locations: 🇺🇸
Yuma Regional Medical Center, Yuma, Arizona, United States
🇺🇸
Northwest Oncology & Hematology, Rolling Meadows, Illinois, United States
🇺🇸
St Joseph Heritage Health - Fullerton, Fullerton, California, United States

and more 76 locations