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

Primary Purpose

Soft Tissue Sarcoma Adult, Undifferentiated Pleomorphic Sarcoma, Epithelioid Sarcoma

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Trabectedin

About this trial

This is an interventional screening trial for Soft Tissue Sarcoma Adult focused on measuring Soft-tissue sarcoma, Predictive biomarkers, Next-generation sequencing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,
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.

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,
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.

Sites / Locations

Institut BergonieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biomarker analysis

Arm Description

This study is a single arm study with biomarker analysis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT04008238

First Posted

July 2, 2019

Last Updated

March 2, 2023

Sponsor

Institut Bergonié

1. Study Identification

Unique Protocol Identification Number

NCT04008238

Brief Title

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

Acronym

PIPER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2020 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Bergonié

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biomarker analysis

Arm Type

Experimental

Arm Description

This study is a single arm study with biomarker analysis

Intervention Type

Drug

Intervention Name(s)

Trabectedin

Intervention Description

- 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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Throughout the treatment period, an expected average of 6 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Throughout the treatment period, an expected average of 6 months

Title

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

Description

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

Time Frame

Throughout the treatment period, an expected average of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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, 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. 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, 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antoine ITALIANO, MD, PhD

Phone

+33 5.56.33.33.33

a.italiano@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Simone MATHOULIN-PELISSIER, MD, PhD

s.mathoulin@bordeaux.unicancer.fr

Facility Information:

Facility Name

Institut Bergonie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antoine ITALIANO, MD, PhD

a.italiano@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Antoine ITALIANO

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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