Spots Global Cancer Trial Database for Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer
Official Title: Phase II Study of VS-6063, A Focal Adhesion Kinase (FAK) Inhibitor, in Patients With KRAS Mutant Non-Small Cell Lung Cancer
Study ID: NCT01951690
Interventions
Study Description
Brief Summary: This is a Phase II, open-label, multicenter, multi cohort, study of VS-6063 (defactinib), a focal adhesion kinase inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC). NSCLC with a KRAS mutation is required for study entry and subjects will be enrolled into 1 of 4 cohorts based on the status of their INK4a/Arf and p53 mutations. The purpose of this study is to demonstrate if VS-6063 (defactinib) improves PFS within each cohort. The safety and tolerability of VS-6063, tumor response rate, progression free survival and overall survival will also be assessed. The pharmacodynamic effects of VS-6063 (defactinib) will be examined in a tumor biopsy and a blood sample.
Detailed Description: Eleven subjects will be enrolled into one of four cohorts: Cohort A (KRAS mutation, wild type INK4a/ARF and wildtype p53), Cohort B (KRAS mutation, INK4s/ARF mutation and wild type p53), Cohort C (KRAS mutation, wild type INK4a/ARF and p53 mutation), and Cohort D (KRAS mutation, INK4a/ARF mutation and p53 mutation). If \>/= 4 patients demonstrate PFS at 12 weeks in each cohort, an additional 23 subjects will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Cancer Center, Anschutz Medical Campus, Denver, Colorado, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Washington University School of Medicine, St. Louis, Missouri, United States
Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon, United States
University of Pittsburgh Medical Center Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Contact Details
Name: David E Gerber, M.D.
Affiliation: University of Texas Southwestern Medical Center
Role: PRINCIPAL_INVESTIGATOR
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