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

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

First Posted Date
2020-10-12
Last Posted Date
2024-05-29
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 6 locations

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

First Posted Date
2020-10-08
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
136
Registration Number
NCT04577833
Locations
🇳🇱

Erasmus MC, Rotterdam, Netherlands

🇵🇱

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, Poland

🇫🇷

HIA Begin, Saint Mande, France

and more 12 locations

Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

First Posted Date
2020-09-14
Last Posted Date
2021-08-05
Lead Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Target Recruit Count
316
Registration Number
NCT04546373
Locations
🇪🇸

Hospital Universitari Dexeus - Grupo Quirónsalud, Barcelona, Spain

🇪🇸

Institut Català d´ Oncologia-Hospital Duran y Reynals, L'Hospitalet De Llobregat, Barcelona, Spain

🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 54 locations

Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2020-09-10
Last Posted Date
2024-10-08
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
141
Registration Number
NCT04544995
Locations
🇬🇧

GSK Investigational Site, Sutton, United Kingdom

Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-08-11
Last Posted Date
2024-12-17
Lead Sponsor
Tongji Hospital
Target Recruit Count
67
Registration Number
NCT04507841
Locations
🇨🇳

Tongji Hospital, Wuhan, Hubei, China

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

First Posted Date
2020-08-04
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
696
Registration Number
NCT04497844
Locations
🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

Houston Metro Urology, Houston, Texas, United States

🇧🇪

Jolimont, Haine-St-Paul, Belgium

and more 387 locations

Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer

First Posted Date
2020-07-30
Last Posted Date
2024-01-19
Lead Sponsor
Mayo Clinic
Target Recruit Count
22
Registration Number
NCT04493060
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-07-17
Last Posted Date
2024-02-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
666
Registration Number
NCT04475939
Locations
🇬🇧

GSK Investigational Site, Wrexham, United Kingdom

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