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NCT02163720
Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
trial testing Yondelis®-Caelyx® in Ovarian Cancer in 101 participants. Completed in 18 September 2018.
1 March 2017
Quick facts
| Lead sponsor | ARCAGY/ GINECO GROUP |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 101 |
| Start date | 10 July 2014 |
| Primary completion | 1 March 2017 |
| Estimated completion | 18 September 2018 |
| Sites | 33 locations across France |
Drugs / interventions tested
- Yondelis®-Caelyx® — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
ARCAGY/ GINECO GROUP — full company profile →
Who can join
18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
Time frame: Patient will be followed during 12 months
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
Sponsor's own description
The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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A narrative review of tumor-associated macrophages in lung cancer: regulation of macrophage polarization and therapeutic implications.
Sedighzadeh SS, Khoshbin AP, Razi S, Keshavarz-Fathi M, et al · · 2021 · cited 160× · PMID 34012800 · DOI 10.21037/tlcr-20-1241 -
PEGylated Lipid Nanoparticle Formulations: Immunological Safety and Efficiency Perspective.
Tenchov R, Sasso JM, Zhou QA. · · 2023 · cited 159× · PMID 37162501 · DOI 10.1021/acs.bioconjchem.3c00174 -
Targeted Nanocarrier-Based Drug Delivery Strategies for Improving the Therapeutic Efficacy of PARP Inhibitors against Ovarian Cancer.
Gralewska P, Gajek A, Marczak A, Rogalska A. · · 2024 · cited 21× · PMID 39125873 · DOI 10.3390/ijms25158304 -
Combinational use of trabectedin and pegylated liposomal doxorubicin for recurrent ovarian cancer: a meta-analysis of phase III randomized controlled trials.
Li C, Qiao S, Kang M, Gao X, et al · · 2023 · cited 3× · PMID 38186978
Verify or expand the search:
- PubMed search for NCT02163720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other ARCAGY/ GINECO GROUP trials
Trials by the same sponsor.
- NCT06715241 — A MULTICENTER, SEEKING SIGNAL, RANDOMISED, OPEN-LABEL PHASE II OF RELATLIMAB AND NIVOLUMAB VS NIVOLUMAB ALONE IN LOCALLY · Phase 2 · active not recruiting
- NCT06599463 — Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric · completed
- NCT06660147 — Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer · recruiting
- NCT05364905 — Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Ca · completed
- NCT04256213 — COL Immunotherapy Before Radiochimio + Ipilimumab · NA · completed
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 NCT02163720 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ARCAGY/ GINECO GROUP
- Last refreshed: 28 September 2020
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/NCT02163720.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing