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NCT07059676: LIBINI-1

Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer

Not yet recruiting Last updated 11 July 2025
What this trial tests

trial testing Zejula (Niraparib) in Advanced Ovarian Cancer in 120 participants. Not yet recruiting.

Timeline
25 July 2025
Primary endpoint
31 December 2027
31 March 2028

Quick facts

Lead sponsorClinica Universidad de Navarra, Universidad de Navarra
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment120
Start date25 July 2025
Primary completion31 December 2027
Estimated completion31 March 2028

Drugs / interventions tested

Conditions studied

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

18 and older, female only, with Advanced Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PARPi inhibitors have been incorporated into managing first-line advanced ovarian cancer with different approvals depending on homologous recombination (HR) status. Niraparib has received approval independent from HR status. Although the benefit is more remarkable in HR-deficient patients, there is no biomarker to predict sustained response to niraparib at the start of treatment helping the clinician to make decisions among the different treatment options. The aim of the LIBINI-1 (Liquid biopsy for predicting niraparib benefit if 1st line) study is to identify predictive biomarkers of sustained response to niraparib using liquid biopsy with two different technologies: 1. Proteomic and secretome analysis tools. The first part of the LIBINI-1 project is to create a platform for rapid screening and analysis by multiple detections of niraparib response-associated proteins in patients with advanced ovarian cancer. 2. ctDNA analysis. The second part of the LIBINI-1 project is to correlate the baseline level of ctDNA and change in ctDNA at 4 and 12 weeks with the benefit to niraparib.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Advanced Ovarian Cancer

Currently open trials in the same condition.

Other Clinica Universidad de Navarra, Universidad de Navarra trials

Trials by the same sponsor.

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Data sources for this page

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