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

Synovial Sarcoma Clinical Trial

— PIPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04008238
• Other study ID #: IB 2019-02
• Secondary ID: 2019-A02137-50
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: Institut Bergonié
• Contact: Antoine ITALIANO, MD, PhD
• Phone: +33 5.56.33.33.33
• Email: a.italiano[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years,

2. 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),

3. Locally advanced/unresectable and/or metastatic disease,

4. Eastern Cooperative Oncology Group (ECOG) performance status = 2 (Appendix 1),

5. Measurable disease according to RECIST v1.1,

6. Indication of trabectedin according to market authorization,

7. At least one target lesion that can be biopsied for research,

8. Women of childbearing potential must have a negative serum pregnancy test before study entry,

9. Patient with a social security in compliance with the French law,

10. Voluntary signed and dated written informed consent prior to any study specific procedure,

11. 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.

Exclusion Criteria:

1. Previous treatment with trabectedin,

2. Known hypersensitivity to any of its components,

3. Patients with an active serious or uncontrolled infection upon investigator judgement,

4. Radiological evidence of symptomatic or progressive brain metastases,

5. Abnormal coagulation contraindicating biopsy,

6. Any medical and/or biological contra-indication to treatment by trabectedin as per market authorization specification (as per investigator judgement),

7. Patients unable to receive corticotherapy,

8. 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,

9. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),

10. 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,

11. Individuals deprived of liberty or placed under guardianship,

12. Pregnant or breast feeding women,

13. Previous enrolment in the present study.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety profile of trabectedin: Common Terminology Criteria for Adverse Events version 5	Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.	Throughout the treatment period, an expected average of 6 months
Secondary	Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5	Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.	Throughout the treatment period, an expected average of 6 months