Soft Tissue Sarcoma AdultPIPERNCT04008238
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients
A study testing Trabectedin in people with Soft Tissue Sarcoma Adult and Undifferentiated Pleomorphic Sarcoma, run by Institut Bergonié at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma Adult, Undifferentiated Pleomorphic Sarcoma, Epithelioid Sarcoma
- What is being tested?
- Trabectedin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma Adult, Undifferentiated Pleomorphic Sarcoma, Epithelioid Sarcoma, Solitary Fibrous Tumors, Hemangioendothelioma, Desmoplastic Round Cell Tumor
- Being tested
- Trabectedin
- Keywords
- Soft-tissue sarcoma, Predictive biomarkers, Next-generation sequencing
- Medical subject headings
- Histiocytoma, Malignant Fibrous, Sarcoma, Solitary Fibrous Tumors, Hemangioendothelioma, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
- 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 group | Role | What they receive |
|---|---|---|
| Biomarker analysis | Experimental | This study is a single arm study with biomarker analysis Receives: Drug: Trabectedin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Measured: Throughout the treatment period, an expected average of 6 months
Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Measured: Throughout the treatment period, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Jan 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008238
- Sponsor's protocol ID
- IB 2019-02
- Other IDs
- 2019-A02137-50
- Acronym
- PIPER
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2019
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients
- ClinicalTrials.gov ID
- NCT04008238
- Acronym / sponsor ID
- PIPER / IB 2019-02
- Conditions
- Soft Tissue Sarcoma Adult, Undifferentiated Pleomorphic Sarcoma, Epithelioid Sarcoma, Solitary Fibrous Tumors, Hemangioendothelioma, Desmoplastic Round Cell Tumor
- Keywords
- Soft-tissue sarcoma, Predictive biomarkers, Next-generation sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker analysis | Experimental | Drug: TrabectedinThis study is a single arm study with biomarker analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Biomarker analysis |
Primary outcome
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.
2 secondary outcomes
Safety profile of trabectedin: Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment period, an expected average of 6 months
Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment period, an expected average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabectedin in people with Soft Tissue Sarcoma Adult and Undifferentiated Pleomorphic Sarcoma, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of trabectedin: objective response [OR] or stable disease [SD] > 6 months (time frame: Throughout the treatment period, an expected average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.