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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 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
Related News

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

Phase 1
Conditions
Lung Cancer
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
Terminated
Conditions
Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Interventions
First Posted Date
2019-03-27
Last Posted Date
2025-01-17
Lead Sponsor
Mario Negri Institute for Pharmacological Research
Target Recruit Count
83
Registration Number
NCT03891576
Locations
🇩🇪

Charité - Universitätsmedizin Berlin, Berlin, Germany

🇩🇪

University Hospital Dresden, Dresde, Germany

🇩🇪

Kliniken Essen Mitte, Essen, Germany

and more 9 locations

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

Phase 1
Active, not recruiting
Conditions
Urothelial Carcinoma
Bladder Cancer
Interventions
Drug: Enfortumab Vedotin
First Posted Date
2019-03-11
Last Posted Date
2025-04-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
272
Registration Number
NCT03869190
Locations
🇺🇸

Stanford Cancer Center, Stanford, California, United States

🇫🇷

Institut Claudius Regaud, Toulouse, France

🇺🇸

UCLA Department of Medicine, Los Angeles, California, United States

and more 31 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
Gastric Cancer
Adenocarcinoma
Esophageal Cancer
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

Niraparib, Temozolomide and Atezolizumab in Treating Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer With a Complete or Partial Response to Platinum-Based First-Line Chemotherapy

Phase 1
Suspended
Conditions
Stage IVB Lung Cancer AJCC v8
Extensive Stage Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Advanced Malignant Solid Neoplasm
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Interventions
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
First Posted Date
2019-02-05
Last Posted Date
2025-02-24
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
74
Registration Number
NCT03830918
Locations
🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer

Phase 3
Withdrawn
Conditions
Ovarian Cancer
Interventions
First Posted Date
2019-01-16
Last Posted Date
2021-07-15
Lead Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Registration Number
NCT03806049
Locations
🇳🇴

Norwegian Radium Hospital, Oslo, Norway

🇫🇮

Tampere University Hospital, Tampere, Finland

🇳🇴

Haukeland University Hospital, Bergen, Haukeland, Norway

and more 4 locations

European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer

Phase 2
Completed
Conditions
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Ovarian Cancer
Interventions
First Posted Date
2018-12-21
Last Posted Date
2023-09-15
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
122
Registration Number
NCT03783949
Locations
🇮🇹

Azienda Ospedaliero Bologna, Bologna, Italy

🇩🇪

Universitätsklinikum Dresden, Dresden, Germany

🇦🇹

Medical University of Innsbruck, Innsbruck, Austria

and more 10 locations

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

First Posted Date
2018-12-07
Last Posted Date
2025-05-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1000
Registration Number
NCT03768063
Locations
🇩🇪

Universitaets-Hautklinik Tuebingen, Tübingen, Germany

🇩🇪

Universitaettsklinikum Tübingen, Tübingen, Germany

🇩🇪

Universitätsklinik Tübingen, Tübingen, Germany

and more 83 locations

Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer

Phase 2
Completed
Conditions
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Interventions
First Posted Date
2018-11-30
Last Posted Date
2024-06-07
Lead Sponsor
Takeda
Target Recruit Count
19
Registration Number
NCT03759587
Locations
🇯🇵

Hirosaki University Hospital, Hirosaki, Aomori, Japan

🇯🇵

Iwate Medical University Hospital, Morioka, Iwate, Japan

🇯🇵

Kurume University Hospital, Kurume, Fukuoka, Japan

and more 24 locations

Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer

Phase 2
Completed
Conditions
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Interventions
First Posted Date
2018-11-30
Last Posted Date
2024-07-16
Lead Sponsor
Takeda
Target Recruit Count
20
Registration Number
NCT03759600
Locations
🇯🇵

Aichi Cancer Center Hospital, Nagoya, Aichi, Japan

🇯🇵

Hirosaki University Hospital, Hirosaki, Aomori, Japan

🇯🇵

Iwate Medical University Hospital, Morioka, Iwate, Japan

and more 30 locations
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