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Not Recruiting
Trial ID: NCT02421588
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
Associate Professor of Obstetrics and Gynecology (Oncology)
Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology
Clinical Professor, Radiology
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
drug: Lurbinectedin (PM01183)
drug: Pegylated liposomal doxorubicin (PLD)
drug: Topotecan
Not Recruiting
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