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出境医 / 临床实验 / Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients (PIPER)
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients (PIPER)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Soft Tissue Sarcoma Adult Undifferentiated Pleomorphic Sarcoma Epithelioid Sarcoma Solitary Fibrous Tumors Hemangioendothelioma Desmoplastic Round Cell Tumor Synovial Sarcoma | Drug: Trabectedin | Not Applicable |
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 (Clinical Trial) |
| Estimated 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 : | January 6, 2020 |
| Estimated Primary Completion Date : | January 2023 |
| Estimated Study Completion Date : | January 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 :
- Efficacy of trabectedin: objective response [OR] or stable disease [SD] > 6 months [ Time Frame: 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 :
- Safety profile of trabectedin: Common Terminology Criteria for Adverse Events version 5 [ Time Frame: Throughout the treatment period, an expected average of 6 months ]Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
- Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5 [ Time Frame: Throughout the treatment period, an expected average of 6 months ]Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years,
- Histology: undifferentiated pleomorphic sarcomas, epithelioid sarcomas, solitary fibrous tumors, hemangioendothelioma, desmoplastic round cell tumors, synovial sarcomas. 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.
Contacts and Locations
Contacts
| Contact: Antoine ITALIANO, MD, PhD | +33 5.56.33.33.33 | a.italiano@bordeaux.unicancer.fr | |
| Contact: Simone MATHOULIN-PELISSIER, MD, PhD | s.mathoulin@bordeaux.unicancer.fr |
Locations
| France | |
| Institut Bergonie | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr | |
| Principal Investigator: Antoine ITALIANO | |
Sponsors and Collaborators
Institut Bergonié
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | July 31, 2020 | ||||||||
| Actual Study Start Date ICMJE | January 6, 2020 | ||||||||
| Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Efficacy of trabectedin: objective response [OR] or stable disease [SD] > 6 months [ Time Frame: 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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients | ||||||||
| Official Title ICMJE | Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Screening |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | 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
|
||||||||
| Study Arms ICMJE | Experimental: Biomarker analysis
This study is a single arm study with biomarker analysis
Intervention: Drug: Trabectedin
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | January 2023 | ||||||||
| Estimated Primary Completion Date | January 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04008238 | ||||||||
| Other Study ID Numbers ICMJE | IB 2019-02 2019-A02137-50 ( Other Identifier: ID-RCB ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Institut Bergonié | ||||||||
| Study Sponsor ICMJE | Institut Bergonié | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Institut Bergonié | ||||||||
| Verification Date | July 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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