Niraparib

Generic Name
Niraparib
Brand Names
Zejula
Drug Type
Small Molecule
Chemical Formula
C19H20N4O
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

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2019-05-20
Last Posted Date
2022-09-10
Lead Sponsor
Tesaro, Inc.
Target Recruit Count
41
Registration Number
NCT03955471
Locations
🇺🇸

GSK Investigational Site, Charlottesville, Virginia, United States

Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

First Posted Date
2019-05-10
Last Posted Date
2022-05-23
Lead Sponsor
University of Turin, Italy
Target Recruit Count
58
Registration Number
NCT03945084
Locations
🇮🇹

Azienda Sanitaria Locale CN2 - Alba e Bra, Alba, Italy

🇮🇹

Azienda USL Toscana Sud Est, Ospedale San Donato, Arezzo, Italy

🇮🇹

Istituto Tumori Giovanni Paolo II - IRCCS, Bari, Italy

and more 17 locations

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients

First Posted Date
2019-05-10
Last Posted Date
2021-10-28
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
20
Registration Number
NCT03945721
Locations
🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute/Brigham and Women's Hospital, Boston, Massachusetts, United States

Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

Phase 2
Conditions
Interventions
First Posted Date
2019-04-24
Last Posted Date
2021-10-22
Lead Sponsor
California Pacific Medical Center Research Institute
Target Recruit Count
41
Registration Number
NCT03925350
Locations
🇺🇸

California Pacific Medical Center Research Institute, San Francisco, California, United States

A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer

Phase 1
Conditions
Interventions
First Posted Date
2019-03-29
Last Posted Date
2019-03-29
Lead Sponsor
Hunan Cancer Hospital
Target Recruit Count
24
Registration Number
NCT03895788
Locations
🇨🇳

Jing Wang, Changsha, Hunan, China

Niraparib in Combination With Osimertinib in EGFR-Mutated Advanced Lung Cancer

Phase 1
Conditions
Interventions
First Posted Date
2019-03-27
Last Posted Date
2020-12-16
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
30
Registration Number
NCT03891615
Locations
🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer)

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-03-27
Last Posted Date
2024-03-13
Lead Sponsor
Mario Negri Institute for Pharmacological Research
Target Recruit Count
83
Registration Number
NCT03891576
Locations
🇩🇪

University Hospital Dresden, Dresde, Germany

🇮🇹

ASST degli Spedali Civili di Brescia, Brescia, Italy

🇮🇹

ASST di Lecco, Lecco, Italy

and more 9 locations

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

First Posted Date
2019-03-11
Last Posted Date
2024-08-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
645
Registration Number
NCT03869190
Locations
🇪🇸

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, Spain

🇪🇸

Hospital Clinico Universitario de Valencia, Valencia, Spain

🇨🇳

National Taiwan University Hospital, Yun-Lin Branch, Huwei Township, Taiwan

and more 38 locations

A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2019-02-15
Last Posted Date
2024-06-04
Lead Sponsor
Shadia Jalal, MD
Target Recruit Count
14
Registration Number
NCT03840967
Locations
🇺🇸

University of Michigan Health System, Ann Arbor, Michigan, United States

🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Indiana Univeristy Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

and more 1 locations
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