Niraparib Tosilate Monohydrate — Drug Intelligence | 22 EU Trials

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22 Registered trials

10 Recruiting

11 Completed trials

14 Sponsors

19 Countries

Phase III

Phase II

Phase III: 7 Phase II: 12 Phase IV: 1 Phase I (Other): 1 Phase I (FiH): 1

Oversight events:

1 serious breach 5 temporary halts 1 corrective measure across 3 trials

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Indications tested

Ovarian cancer 6 Fallopian tube cancer 3 Ovarian cancer stage IV 2 Ovarian cancer stage III 2 Hormone receptor positive HER2 negative breast cancer 1 Small cell lung cancer extensive stage 1 Breast cancer 1 Fallopian tube cancer metastatic 1 Homologous recombination deficiency positive advanced ovarian cancer 1 Non-small cell lung cancer stage IV 1 Small cell lung cancer 1 Non-small cell lung cancer stage IIIB 1

Sponsors using this IMP

Glaxosmithkline Research & Development Limited 5 Tesaro Inc. 4 AGO Research GmbH 2 Arcagy Gineco 1 Asso De Recherche Cancers Gynecologiques 1 ETOP IBCSG Partners Foundation 1 Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting 1 Hospices Civils De Lyon 1 Medica Scientia Innovation Research S.L. 1 Merck Healthcare KGaA 1 Neurotrials LLC 1 Nord Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V. 1

All trials

22 total

A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Careas Maintenance Treatment In Patients With Locally Advanced Or Metastat… Pending

2024-519519-32-00 Phase II 1 country Universita' Degli Studi Di Torino
A study comparing niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma Recruiting

2024-513077-48-00 Phase III 8 countries Neurotrials LLC
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
An international multicentric randomized phase II evaluating dostarlimab in combination with niraparib versus niraparib alone compared to ch… Recruiting

2024-516782-36-00 Phase II 3 countries Asso De Recherche Cancers Gynecologiques
Phase II Study to Assess the Efficacy of Niraparib Rechallenge after Surgery in Ovarian Cancer Patients with Oligometastatic Progression (Th… Recruiting

2023-508258-24-00 Phase II 1 country Medica Scientia Innovation Research S.L.
N-PLUS Recruiting

2022-502559-69-01 Phase II 6 countries Nord Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V.
A clinical study to test the effect of niraparib and immunotherapy, for patients with small cell lung cancer (SCLC) that is positive for SLF… Recruiting

2022-502092-33-00 Phase II 5 countries ETOP IBCSG Partners Foundation
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
EXTENSION STUDY FOR PATIENTS WHO HAVE COMPLETED A PRIOR GLAXOSMITHKLINE/TESARO-SPONSORED NIRAPARIB STUDY AND ARE JUDGED BY THE INVESTIGATOR … Recruiting

2023-506618-29-00 Phase II 6 countries Glaxosmithkline Research & Development Limited
ProTarget - A Danish Nationwide Clinical Trial on Targeted Anti‐Cancer Treatment based on Genomic Profiling Recruiting

2023-510527-29-00 Phase II 1 country Rigshospitalet
DRUP trial Recruiting

2023-509152-33-00 Phase II 1 country Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Tuvusertib Combined with Niraparib or Lartesertib in Participants with Epithelial Ovarian Cancer (DDRiver EOC 302) Ended

2024-511202-23-00 Phase II 8 countries Merck Healthcare KGaA
A randomized phase II trial of Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer eligible fo… Ended

2024-516959-40-00 Phase II 1 country AGO Research GmbH
Efficacy and Safety Comparison of Niraparib to Placebo in Participants with HER2 Negative BRCAmut or Triple-Negative Breast Cancer with Mole… Ended

2023-504454-35-00 Phase III 4 countries Glaxosmithkline Research & Development Limited
A study to determine whether the addition of Dostarlimab (TSR-042) delays recurrence of advanced endometrial cancer Ended

2023-506551-23-00 Phase III 13 countries Tesaro Inc.
The FIRST (First-line ovarian cancer treatment with Niraparib plus TSR-042) Study Ended

2024-510605-28-00 Phase III 13 countries Tesaro Inc.
"OPAL Master Protocol Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of T… Ended

2023-505097-16-00 Phase II 1 country Tesaro Inc.
Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumours Ended

2024-511071-16-00 Phase I (Other) 5 countries Glaxosmithkline Research & Development Limited
NIRAPK: Study of the relationships between pharmacokinetic properties (PK) and hematological toxicity of niraparib in ovarian cancer Ended

2024-513856-14-00 Phase IV 1 country Hospices Civils De Lyon
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants wit… Ended

2023-508443-40-00 Phase III 14 countries Glaxosmithkline Research & Development Limited
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovar… Ended

2023-508010-42-00 Phase III 12 countries Tesaro Inc.
A study to investigate the safety, tolerability, pharmacokinetics (PK), and preliminary anticancer activity of GSK4524101 alone or with nira… Ended

2024-520197-36-00 Phase I (FiH) 8 countries Glaxosmithkline Research & Development Limited

Showing 1–22 of 22 trials

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