Informations générales (source: ClinicalTrials.gov)
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients (PIPER)
Interventional
N/A
Institut Bergonié (Voir sur ClinicalTrials)
janvier 2020
janvier 2025
08 mars 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Institut Bergonie - 33076 - Bordeaux - France | Antoine ITALIANO, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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.