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

NCT04008238 | Completed

• 2 other identifiers: IB 2019-022019-A02137-50
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Soft-tissue sarcoma; Predictive biomarkers; Next-generation sequencing

Outcome Measures

Primary Outcomes (1)

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

  Efficacy of trabectedin is defined as objective response \[OR\] or stable disease \[SD\] \> 6 months. Absence of efficacy is defined as progressive disease \[PD\] within 2 months.

  Throughout the treatment period, an expected average of 6 months

Secondary Outcomes (2)

• Safety profile of trabectedin: Common Terminology Criteria for Adverse Events version 5

  Throughout the treatment period, an expected average of 6 months

• Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5

  Throughout the treatment period, an expected average of 6 months

Study Arms (1)

Biomarker analysis

EXPERIMENTAL

This study is a single arm study with biomarker analysis

Drug: Trabectedin

Interventions

Trabectedin DRUG

\- 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

Biomarker analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Patient with a social security in compliance with the French law,
• Voluntary signed and dated written informed consent prior to any study specific procedure,
• Women must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of trabectedin. Men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of trabectedin. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>=1 year.

You may not qualify if:

• 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,
• Abnormal coagulation contraindicating biopsy,
• Any medical and/or biological contra-indication to treatment by trabectedin as per market authorization specification (as per investigator judgement),
• Patients unable to receive corticotherapy,
• Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
• Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
• Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol,
• Individuals deprived of liberty or placed under guardianship,
• Pregnant or breast feeding women,
• Previous enrolment in the present study.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (1)

Institut Bergonie

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous; Sarcoma; Solitary Fibrous Tumors; Hemangioendothelioma; Sarcoma, Synovial

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Hemangioma; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: January 6, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)