Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma

Conditions

• Malignant Pleural Mesothelioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• defactinib (VS-6063) — DRUG
• Placebo — DRUG
  Sugar pill manufactured to mimic defactinib tablet

Study Details

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.

Key Dates

Start date

Sep 30, 2013

Status verified

Mar 2016

Primary completion

Jan 31, 2016

Completion

Jan 31, 2016

Study Design

Enrollment

344 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: defactinib (VS-6063)
  2 x 200 mg defactinib (VS-6063) tablets, administered orally, twice daily
• Placebo Comparator: Placebo
  2 placebo tablets, administered orally, twice daily

Primary Outcome Measure

Compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving defactinib (VS-6063) or placebo [ Time Frame: From randomization to end of life, an expected average of 12 months ]

Locations (12)

Find similar trials in San Francisco, CA

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