INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer

Exclusion Criteria

• •1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
• •2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred \< 6 months or \> 12 months from the last dose of platinum
• •3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
• •4. Pre-existing grade \> 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
• •5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
• •6. History of liver disease
• •7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
• •8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
• •9. Prior exposure to trabectedin
• •10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
• •11. Prior severe PLD related toxicity
• •12. Prior exposure to cumulative doses of doxorubicin \>400mg/m2 or epirubicin \>720mg/m2
• •13. Treatment with any investigational product within 30 days prior to inclusion in the study