Clinical Trial

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

Study acronym: ANALLISA
Recruiting Phase 2
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Summary
The ANALLISA study is a fast, proof-of-concept, phase II clinical trial which aims to assess the efficacy of niraparib rechallenge treatment after secondary cytoreductive surgery in ovarian cancer (OC) patients with oligometastatic progression (OMP) after first maintenance therapy with any PARP inhibitor. A total of 30 patients with OC and OMP will be enrolled and will receive treatment with niraparib 300 or 200 mg, according to body weight or platelet count. Patients will start treatment within 8 weeks after surgery and will receive it until progressive disease or treatment discontinuation. The main purpose of the study is to evaluate progression-free survival (PFS) of niraparib rechallenge in OC patients with OMP and no residual disease after secondary cytoreductive surgery.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2023-12-12; most recent amendment 2026-04-17.
Status change: Not Yet Recruiting → Recruiting 2024-08-07
Trial Details
NCT Number NCT06180356
Lead Sponsor MedSIR
Conditions Ovarian Cancer, Oligometastatic Disease, Serous Ovarian Tumor
Enrollment 30 participants
Start Date 2024-12-03
Primary Completion 2028-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-22