RecruitingPhase 2NCT06180356

Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression

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


Sponsor

MedSIR

Enrollment

30 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether women with ovarian cancer that has come back in only a few spots (called oligometastatic progression) can benefit from surgery to remove those spots followed by restarting niraparib — a maintenance pill that was used previously. It examines whether this approach can delay further cancer spread. **You may be eligible if...** - You are a woman 18 or older with high-grade ovarian, fallopian tube, or peritoneal cancer - You previously received niraparib as maintenance therapy and your cancer responded - Your cancer has now come back in only a limited number of spots that can be surgically removed - You are in good health (ECOG performance status 0-1) with a life expectancy over 16 weeks **You may NOT be eligible if...** - Your cancer has spread widely and cannot be surgically removed - You have had prior surgical treatment for recurrent disease - You have certain serious health conditions or poor organ function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib 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

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NCT06180356


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