NCT04008238

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The identification of predictive biomarkers of the clinical benefit of trabectedin is a crucial issue to identify potential responders particularly for non-L sarcomas. Considering that the molecular profile of STS can change over time, an analysis of archival tumor material may not be a reliable method to identify predictive biomarkers of response, and thus high-throughput technologies may be promising to identify STS markers for prediction of response to trabectedin. For study purpose, blood and tumor samples will be obtained for genetic and immunological profiling at baseline, during treatment by trabectedin and at disease progression.

Conditions

• Soft Tissue Sarcoma Adult
• Undifferentiated Pleomorphic Sarcoma
• Epithelioid Sarcoma
• Solitary Fibrous Tumors
• Hemangioendothelioma
• Desmoplastic Round Cell Tumor
• Synovial Sarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin	\- Trabectedin will be prescribed as per market authorization and will be administered by intraveinous infusion (1,5 mg/m²) every 3 weeks. A treatment cycle is defined as a 3-weeks period

Timeline

• Start date: 2020-01-06
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2019-07-05
• Last updated: 2026-03-06

Locations

1 site across 1 country: France