FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer
Status:
Terminated
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase
2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC
plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC).
Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or
fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC
plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs.
paclitaxel), platinum free interval (< 3 vs. 3 to 6 months from last platinum therapy to
subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study,
consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study
(Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects
will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.