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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
trial testing Zejula (Niraparib) in Advanced Ovarian Cancer in 120 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 25 July 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 March 2028 |
Drugs / interventions tested
- Zejula (Niraparib) — full drug profile →
Conditions studied
- Advanced Ovarian Cancer — all drugs for Advanced Ovarian Cancer →
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.
Verify or expand the search:
- PubMed search for NCT07059676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Ovarian Cancer
Currently open trials in the same condition.
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- NCT04862325 — SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS · NA · active not recruiting
- NCT04065009 — The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer · Phase 3 · active not recruiting
- NCT03737643 — Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab a · Phase 3 · active not recruiting
Other Clinica Universidad de Navarra, Universidad de Navarra trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07059676 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Clinica Universidad de Navarra, Universidad de Navarra
- Last refreshed: 11 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07059676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing