Condition
Relapsed Malignant Mesothelioma
Estimated Enrollment: 21
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: VS-6063-104
Study First Received: January 30, 2015
Last Updated: January 26, 2017
Estimated Primary Completion Date: October 2015
Primary Outcome Measures:
Incidence of dose-limiting toxicities (DLTs)|Safety and tolerability of the combination of VS-5584 and VS-6063|Pharmacokinetics of VS-5584 & VS-6063 maximum observed plasma concentration (Cmax)|Pharmacokinetics of VS-5584 & VS-6063 plasma area under the curve from time zero to last quantifiable concentration (AUClast)|Pharmacokinetics of VS-5584 & VS-6063 time to reach maximum observed concentration (Tmax)|Pharmacokinetics of VS-5584 & VS-6063 area under the curve from time zero to extrapolated infinite time (AUCO-inf)|Pharmacokinetics of VS-5584 & VS-6063 apparent oral clearance (CL/F)|Pharmacokinetics of VS-5584 & VS-6063 apparent volume of distribution (Vz/F)|Pharmacokinetics of VS-5584 & VS-6063 trough plasma concentration
Sponsors and Collaborators:
Verastem, Inc.
Website Link: https://ClinicalTrials.gov/show/NCT02372227