Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of
defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not
progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment
with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the
study, each subject must have tumor Merlin status(high or low) established by
immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1
ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be
stratified by tumor Merlin status (high versus low). Progression will be assessed both
locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST)
Version 1.1. Subjects will continue to receive treatment until disease progression or other
discontinuation criteria are met. Following documentation of nonfatal disease progression,
all subjects will be followed for overall survival by telephone contact every 2 months until
end of life or the close of the study.