Phase I Dose Escalation Study of VS-4718 in Subjects With Metastatic Non-Hematologic Malignancies
NCT01849744 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2017-07-28
Summary
This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This clinical study is comprised of 2 parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-4718 in your blood) and the anti-cancer activity of VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.
Conditions
- Non Hematologic Cancers
- Metastatic Cancer
Interventions
- DRUG
-
VS-4718
Sponsors & Collaborators
-
Verastem, Inc.
lead INDUSTRY
Principal Investigators
-
Hagop Youssoufian, MD · Verastem, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2017-04-30
- Completion
- 2017-06-30
Countries
- United States
Study Locations
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