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Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

NCT06180356 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Principal Investigators

  • Alfonso Cortés Salgado · Hospital Universitario Ramón y Cajal, IRYCIS, Madrid (Spain)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180356 on ClinicalTrials.gov