CompletedNot Applicable

Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients

France29 participantsStarted 2020-01-06

Plain-language summary

This is a biology driven, monocentric study, designed to identify biomarkers of activity of trabectedin in patients with advanced non-L soft-tissue sarcoma. The aim of this study is to implement high-throughput profiling technologies to identify predictive biomarkers of trabectedin efficacy through sequential tumor biopsies and blood sample collection in sarcoma patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years,
✓. Histology: undifferentiated pleomorphic sarcomas, epithelioid sarcomas, solitary fibrous tumors, hemangioendothelioma, desmoplastic round cell tumors, synovial sarcomas or other non-leiomyosarcoma/non-liposarcoma softtissue sarcoma. As per the Frech NCI recommendation, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de Référence en Pathologie des Sarcomes des tissus mous et des Viscères),
✓. Locally advanced/unresectable and/or metastatic disease,
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1),
✓. Measurable disease according to RECIST v1.1,
✓. Indication of trabectedin according to market authorization,
✓. At least one target lesion that can be biopsied for research,
✓. Women of childbearing potential must have a negative serum pregnancy test before study entry,

Exclusion criteria

✕. Previous treatment with trabectedin,
✕. Known hypersensitivity to any of its components,
✕. Patients with an active serious or uncontrolled infection upon investigator judgement,
✕. Radiological evidence of symptomatic or progressive brain metastases,

What they're measuring

Efficacy of trabectedin: objective response [OR] or stable disease [SD] > 6 months

Timeframe: Throughout the treatment period, an expected average of 6 months

Trial details

NCT IDNCT04008238

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-31

View on ClinicalTrials.gov More Soft Tissue Sarcoma Adult trials