Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Exclusion Criteria

• •1. Other primary malignancy with \<5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ or other neoplasm judged to entail a low risk of relapse
• •2. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
• •3. Previous radiotherapy to 25% of the bone marrow
• •4. Major surgery within 2 weeks prior to study entry
• •5. Participation in another clinical study with an investigational product, which last dose was taken less than 4 weeks prior to the start of the treatment.
• •6. Persistent toxicities (≥ grade 2) with the exception of alopecia, caused by previous anticancer therapies.
• •7. Pregnancy or breast feeding
• •8. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
• •9. Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
• •10. Known brain metastasis
• •11. Known chronic liver disease (i.e. chronic active hepatitis and cirrhosis)
• •12. Known diagnosis oh human deficiency virus (HIV) infection
• •13. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
• •14. Medical history of hemorrhage or a bleeding event ≥ Grade 3 within 4 weeks prior to the initiation of study treatment
• •15. Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
• •16. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
• •17. Expected non-compliance to medical regimens