|This is a randomized, open-label, active-controlled, multicenter study.
Approximately 670 subjects will be enrolled in this study worldwide, with 335 subjects per planned treatment group.
During the Screening Phase, potential subjects will be assessed for study eligibility after providing informed consent to participate in the study. Baseline radiographic disease assessments must be performed within 30 days before randomization.
At randomization, subjects will be stratified by 4 criteria:
1) the time from the last dose of first-line platinum therapy to disease progression (6 months to 12 months vs >12 months to 24 months vs >24 months),
2) Eastern Cooperative Oncology Group (ECOG) performance status grade (0 vs 1),
3) BRCA 1/2 status (mutation vs no mutation), and
4) prior pegylated liposomal doxorubicin therapy (no vs yes). Subjects will then be randomly assigned in a 1:1 ratio to the trabectedin+DOXIL combination therapy group (Arm A) or to the DOXIL monotherapy group (Arm B).
During the Treatment Phase, subjects will receive study drug by IV infusion on Day 1 of a 21-day cycle in Arm A and on Day 1 of a 28-day cycle in Arm B.