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

Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).

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