Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

Inclusion Criteria:

   - Age >/= 18 years

   - Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary
   peritoneal cancer.

   - Platinum-resistant disease (PFI: 1-6 months after last platinum-containing
   chemotherapy).

   - Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
   v.1.1 criteria

   - No more than three prior systemic chemotherapy regimens

   - Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2

   - Adequate hematological, renal, metabolic and hepatic function

Exclusion Criteria:

   - Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active
   hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major
   illness

   - Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.

   - Requirement of permanent or frequent (i.e., once per week) external drainages within
   two weeks prior to randomization