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