Trial Information

An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

This is a multicenter, open-label (all people know the identity of the intervention),
randomized (study medication is assigned by chance), Phase 3 study comparing the combination
of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who
were previously treated and for whom first-line platinum-based chemotherapy regimen has
failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms
(DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be
stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and
baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety
will be evaluated on the basis of adverse events, clinical laboratory tests, physical
examination, vital signs assessment and cardiovascular safety assessment. An interim
analysis of overall survival will be performed in conjunction with progression-free survival
analysis during the study. Treatment will be continued until disease progression occurred or
until patients experienced a confirmed complete response for at least 2 cycles.
Continuation of treatment in select individual patients beyond this study end date will be
allowed if the investigator determined that the patient is benefiting from treatment, is
eligible to receive further therapy, and consents to treatment. If disease progression has
not occurred at treatment termination, then disease assessment will continue every 8 weeks
until there is evidence of disease progression or death, or until the clinical data cutoff
date, or until the start of first subsequent anticancer therapy, whichever is earlier.