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

NCT01870609 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2017-01-30

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

DRUG

defactinib (VS-6063)

DRUG

Placebo

Sugar pill manufactured to mimic defactinib tablet

Sponsors & Collaborators

  • Verastem, Inc.

    lead INDUSTRY

Principal Investigators

  • Hagop Youssoufian · Verastem, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870609 on ClinicalTrials.gov