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Terminated

A Phase 1 Dose Escalation Study of VS-5584 Administered in Combination With VS-6063, in Subjects With Relapsed Malignant Mesothelioma

By April 24, 2017No Comments

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

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