Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin

Inclusion Criteria

• •1. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent and any locally required authorization before any study-specific procedures, including screening evaluations, sampling, and analyses
• •2. Diagnosis of well differentiated/dedifferentiated liposarcoma, mixoid round cell liposarcoma, leiomyosarcoma or synovial sarcoma
• •3. Persistent or locally relapsed and/or metastatic disease
• •4. Pathology specimens available for centralized review (central review is not mandatory prior to start the treatment, but within a month from screening, tumor sample must be sent to central pathology reviewer for a retrospective diagnosis confirmation).
• •5. Age ≥ 18 years
• •6. Adequate bone marrow function
• •7. Adequate organ function,
• •8. Eastern Cooperative Oncology Group Performance Status ≤ 2
• •9. One or more previous systemic treatments with anthracyclines with or without ifosfamide (unless one or both are clinically contraindicated)
• •10. Measurable disease. Patient who received radiotherapy within 3 weeks form the treatment start, can be included as long there is a measurable lesion outside of the irradiation field
• •11. A minimum of 3 weeks since any previous chemotherapy treatment
• •12. Recovery from toxic effects of prior therapies to (Grade 1 or lower)
• •13. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.