Ovarian Cancer Clinical Trial
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Summary
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).
Eligibility Criteria
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
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There is 1 Location for this study
Peoria Arizona, , United States
Greenbrae California, , United States
La Jolla California, , United States
Los Angeles California, , United States
Los Angeles California, , United States
Palo Alto California, , United States
San Francisco California, , United States
Santa Maria California, , United States
West Hills California, , United States
Augusta Georgia, , United States
Indianapolis Indiana, , United States
Covington Louisiana, , United States
Scarborough Maine, , United States
Brick New Jersey, , United States
Albany New York, , United States
New York New York, , United States
Asheville North Carolina, , United States
Charlotte North Carolina, , United States
Charlotte North Carolina, , United States
Durham North Carolina, , United States
Columbus Ohio, , United States
Dayton Ohio, , United States
Pittsburgh Pennsylvania, , United States
Greenville South Carolina, , United States
Nashville Tennessee, , United States
Fort Worth Texas, , United States
Houston Texas, , United States
Charlottesville Virginia, , United States
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