Niraparib — Drug Intelligence | 13 EU Trials

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13 Registered trials

6 Recruiting

6 Completed trials

12 Sponsors

18 Countries

Phase III

Phase II

Phase III: 6 Phase II: 5 Phase I/II: 1 Phase I (Other): 1

Oversight events:

1 serious breach 2 urgent safety measures across 2 trials

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Indications tested

Ovarian cancer 3 Prostate cancer metastatic 2 Squamous cell carcinoma of head and neck 2 Renal cell carcinoma 1 DNA mismatch repair deficiency test 1 Oropharyngeal squamous cell carcinoma 1 Triple negative breast cancer 1 Non-small cell lung cancer stage IV 1 Non-small cell lung cancer 1 Ovarian cancer recurrent 1 Skin cancer 1 Fallopian tube cancer 1

Sponsors using this IMP

Janssen - Cilag International 2 AGO Research GmbH 1 Arcagy Gineco 1 F. Hoffmann-La Roche AG 1 Fondazione GONO Plus 1 Fondazione Policlinico Universitario Agostino Gemelli IRCCS 1 Grupo Espanol De Tratamiento De Tumores De Cabeza Y Cuello 1 Institut Gustave Roussy 1 K-Group Beta Inc. 1 Oslo University Hospital HF 1 Unicancer 1 Universita' Degli Studi Di Torino 1

All trials

13 total

A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with pleural mesothelioma posit… Pending

2024-515555-38-01 Phase II 1 country Universita' Degli Studi Di Torino
Evaluation of Niraparib alone compared to the combination of Niraparib and Bevacizumab in patients receiving chemotherapy for newly diagnose… Recruiting

2024-516066-11-00 Phase III 4 countries AGO Research GmbH
Personalized medicine for advanced biliary cancer patients Recruiting

2023-508100-38-00 Phase III 2 countries Unicancer
Evaluation of an initial treatment with bevacizumab in combination with chemotherapy and then in combination with niraparib in maintenance i… Recruiting

2023-504166-37-00 Phase II 4 countries Arcagy Gineco
Improving public cancer care by implementing precision medicine in Norway Recruiting

2023-507894-16-00 Phase II 1 country Oslo University Hospital HF
Induction and maintenance treatment with PARP inhibitor and immunotherapy in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). PRI… Recruiting

2024-516798-54-00 Phase II 1 country Fondazione GONO Plus
Randomized phase III trial on NIraparib-Dostarlimab vs physician’s choice CHEmotherapy in recurrent, ovarian, fallopian tube or primary peri… Recruiting

2024-516649-38-00 Phase III 4 countries Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head a… Ended

2024-516779-33-00 Phase I/II 1 country Grupo Espanol De Tratamiento De Tumores De Cabeza Y Cuello
A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment … Ended

2023-506365-64-00 Phase III 13 countries Janssen - Cilag International
An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizu… Ended

2023-506184-34-00 Phase III 11 countries F. Hoffmann-La Roche AG
A Phase 3 Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment … Ended

2023-503254-12-00 Phase III 10 countries Janssen - Cilag International
Phase 1/2 Study of ZN-c3 and Niraparib and ZN-c3 Monotherapy in Platinum-Resistant Ovarian Cancer Ended

2024-515196-35-00 Phase I (Other) 1 country K-Group Beta Inc.
An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA r… Ended

2024-514855-13-00 Phase II 1 country Institut Gustave Roussy

Showing 1–13 of 13 trials

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