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