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RECRUITING
NCT06180356
PHASE2

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

Sponsor: MedSIR

View on ClinicalTrials.gov

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 6 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.

Official title: Phase II Study to Assess the Efficacy of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression (The ANALLISA Study)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-12-03

Completion Date

2028-01

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

DRUG

Niraparib oral tablets

Niraparib 300 or 200 mg according to body weight or platelet count. Tablets will be taken orally, once daily, continuously (in 28-day cycles).

Locations (14)

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Hospital de Cruces

Barakaldo, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Institut Català d' Oncologia Girona (ICO)

Girona, Spain

Complejo Hospitalario de Jaén

Jaén, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Spain

Hospital Arnau de Vilanova de Valencia

Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain