Zejula 100 mg film-coated tablets
Sponsors
Glaxosmithkline Research & Development Limited, Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting, Artios Pharma Limited, Institut Gustave Roussy, K-Group Beta Inc.
Conditions
Advanced ovarianAdvanced solid tumorAdvanced solid tumorsCarcinomaDNA repair-deficient or platinum-sensitive solid tumorsFIGO stage III/IV (except FIGO IIIA2 without nodal involvement)HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)Metastatic solid tumors
Phase 1
A Phase 1, Multicentre, Open-label, Dose-escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Patients with Recurrent or Refractory Solid Tumours
CompletedCTIS2024-511071-16-00
Start: 2022-02-10End: 2025-03-04Target: 121Updated: 2024-10-28
A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors
Not yet recruitingCTIS2023-509220-17-00
Target: 55Updated: 2025-06-12
Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib
and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head and
Neck squamous cell carcinoma (RADIAN)
RecruitingCTIS2024-516779-33-00
Start: 2023-11-08Target: 34Updated: 2026-01-21
A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib and ZN-c3 Monotherapy in Subjects with Platinum-resistant Ovarian Cancer.
RecruitingCTIS2024-515196-35-00
Start: 2022-09-29Target: 150Updated: 2026-01-06
A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.
CompletedCTIS2024-520197-36-00
End: 2025-12-09Target: 31Updated: 2025-11-10
Phase 2
An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and are Judged by the Investigator to Benefit from Continued Treatment with Niraparib
RecruitingCTIS2023-506618-29-00
Start: 2021-09-22Target: 8Updated: 2025-10-22
A Dutch National Study on behalf of the Center for Personalized Cancer Treatment (CPCT) to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to determine the Potential Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile: The Drug Rediscovery Protocol (DRUP trial)
RecruitingCTIS2023-509152-33-00
Start: 2016-07-25Target: 3000Updated: 2025-12-19
An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors (NIRADO)
CompletedCTIS2024-514855-13-00
End: 2025-02-25Target: 112Updated: 2024-07-09
A randomized phase II trial of Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer eligible for platinum-based chemotherapy.
supported by:
DIAGNOSTIC PROTOCOL for the VENTANA FOLR1 (FOLR1-2.1) CDx Assay Ventana No. RD004881; Protocol Document No. D152967
Active, not recruitingCTIS2024-516959-40-00
Start: 2021-08-17Target: 136Updated: 2025-12-05
Induction and maintenance treatment with PARP inhibitor and immunotherapy in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC). PRIME H&N study
RecruitingCTIS2024-516798-54-00
Start: 2021-02-08Target: 49Updated: 2024-11-11