Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
Verastem, Inc.
Study ID
NCT01951690
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2013
Status verified
Apr 2017
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VS-6063 (defactinib)
    Administered orally BID in a 21 day cycle

Primary Outcome Measure

Demonstrate that VS-6063 (defactinib), will improve PFS at 12 weeks (PFS12) within each cohort. [ Time Frame: From baseline through 12 weeks of treatment ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer Center, Anschutz Medical CampusDenverColorado80045-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Washington University School of MedicineSt LouisMissouri63110-
Knight Cancer Institute, Oregon Health and Science UniversityPortlandOregon97239-
University of Pittsburgh Medical Center Cancer CenterPittsburghPennsylvania15232-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University of Texas Southwestern Medical CenterDallasTexas75390-8852-
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229-3900-

Find similar trials in Denver, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Colorado Cancer Center, Anschutz Medical Campus· Denver, COWinship Cancer Institute of Emory University· Atlanta, GAJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDWashington University School of Medicine· St Louis, MOKnight Cancer Institute, Oregon Health and Science University· Portland, ORUniversity of Pittsburgh Medical Center Cancer Center· Pittsburgh, PA

Related Studies