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

Sponsor
Institut Bergonié (Other)
Overall Status
Recruiting
CT.gov ID
NCT04008238
Collaborator
(none)
200
1
1
35.8
5.6

Study Details

Study Description

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.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biomarker analysis

This study is a single arm study with biomarker analysis

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

Outcome Measures

Primary Outcome Measures

  1. Efficacy of trabectedin: objective response [OR] or stable disease [SD] > 6 months [Throughout the treatment period, an expected average of 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.

Secondary Outcome Measures

  1. Safety profile of trabectedin: Common Terminology Criteria for Adverse Events version 5 [Throughout the treatment period, an expected average of 6 months]

    Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.

  2. Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5 [Throughout the treatment period, an expected average of 6 months]

    Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Bergonie Bordeaux France 33076

Sponsors and Collaborators

  • Institut Bergonié

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT04008238
Other Study ID Numbers:
  • IB 2019-02
  • 2019-A02137-50
First Posted:
Jul 5, 2019
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Bergonié
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2022