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 can...

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.
...

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

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 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

The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer

Phase 2

Not yet recruiting

Conditions: Recurrent Small Cell Lung Cancer

Interventions: Radiation: SBRT
Drug: Toripalimab
Drug: Niraparib

First Posted Date: 2021-12-17

Last Posted Date: 2022-05-02

Lead Sponsor: Wuhan University

Target Recruit Count: 57

Registration Number: NCT05162196

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

Phase 2

Completed

Conditions: Platinum-resistant Recurrent Clear Cell Ovarian Cancer

Interventions: Drug: Niraparib
Drug: Anlotinib

First Posted Date: 2021-11-23

Last Posted Date: 2023-01-31

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 6

Registration Number: NCT05130515

Locations: 🇨🇳
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

Phase 2

Not yet recruiting

Conditions: Primary Peritoneal Cancer
Recurrent Ovarian Cancer
Recurrent Fallopian Tube Cancer

Interventions: Drug: Niraparib
Drug: Dostarlimab

First Posted Date: 2021-11-19

Last Posted Date: 2022-07-27

Lead Sponsor: AGO Research GmbH

Target Recruit Count: 100

Registration Number: NCT05126342

Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

Early Phase 1

Recruiting

Conditions: Glioblastoma Multiforme
Glioma
Glioblastoma Multiforme of Brain
Glioblastoma
Glioma, Malignant
GBM

Interventions: Drug: Niraparib
Radiation: Radiation therapy

First Posted Date: 2021-10-13

Last Posted Date: 2024-02-22

Lead Sponsor: Nader Sanai

Target Recruit Count: 42

Registration Number: NCT05076513

Locations: 🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

Phase 2

Recruiting

Conditions: High Grade Serous Cancer
High Grade Endometrioid Cancer
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer

Interventions: Drug: Niraparib
Drug: Bevacizumab
Drug: Dostarlimab
Drug: Paclitaxel

First Posted Date: 2021-10-01

Last Posted Date: 2024-01-17

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 40

Registration Number: NCT05065021

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Study of Niraparib in Patients with Ovarian Cancer in Clinical Practice

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Niraparib

First Posted Date: 2021-08-25

Last Posted Date: 2024-11-13

Lead Sponsor: Takeda

Target Recruit Count: 300

Registration Number: NCT05021562

Locations: 🇯🇵
Takeda Selected Site, Tokyo, Japan

Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

Phase 3

Recruiting

Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer

Interventions: Drug: Carboplatin
Drug: Paclitaxel
Drug: Niraparib
Drug: Bevacizumab

First Posted Date: 2021-08-17

Last Posted Date: 2024-04-08

Lead Sponsor: AGO Study Group

Target Recruit Count: 970

Registration Number: NCT05009082

Locations: 🇩🇪
Klinikum Neumarkt, Neumarkt, Germany
🇩🇪
MVZ Nordhausen, Nordhausen, Germany
🇩🇪
Klinikum St. Marien Amberg, Amberg, Germany

and more 57 locations

Niraparib in Tumors Metastatic to the CNS

Phase 2

Recruiting

Conditions: Metastatic Cancer
Central Nervous System Cancer

Interventions: Drug: Niraparib

First Posted Date: 2021-08-05

Last Posted Date: 2024-12-12

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 20

Registration Number: NCT04992013

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

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