drugset / Trial / NCT02004028

Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants

NCT02004028

Phase 2 Terminated 35 enrolled Verastem, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days or 100 mg formulation twice daily for 21 days. Pre- and post-treatment biopsies and blood samples will be collected. The purpose of this study is to assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor response rate to VS-6063 (defactinib) will be also be assessed.

Timeline

Start
2013-12-12
Primary completion
2019-06-19
Completion
2019-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Defactinib Small molecule 100 mg Oral
Subject Defactinib Small molecule 400 mg Oral