- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01951690
Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer
Phase II Study of VS-6063, A Focal Adhesion Kinase (FAK) Inhibitor, in Patients With KRAS Mutant Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Colorado
-
Denver, Colorado, United States, 80045
- University of Colorado Cancer Center, Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Oregon
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Portland, Oregon, United States, 97239
- Knight Cancer Institute, Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University Of Pittsburgh Medical Center Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Texas
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Dallas, Texas, United States, 75390-8852
- University of Texas Southwestern Medical Center
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San Antonio, Texas, United States, 78229-3900
- The University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 18 years of age.
- ECOG (Eastern Cooperative Oncology Group) Performance Score of 0 or 1.
- Histologic or cytologic confirmation of non-small cell lung cancer (NSCLC)
- Molecular characterization of the tumor demonstrating a KRAS mutation by a CLIA-certified assay. Adequate archival tissue, tissue core biopsy specimen, or DNA samples must be available for central testing of INK4a/Arf and p53 if not previously performed by a CLIA certified lab.
- Documented evidence of distant metastasis or locoregional recurrence per required assessments within 28 days prior to starting study therapy.
Note: Histologic confirmation of metastatic disease is not required.
- For patients with brain metastases, the following criteria must be met:
Previously untreated brain metastases that are asymptomatic and not requiring steroids are permitted.
Previously treated brain metastases are permitted if most recent CNS radiographic imaging demonstrates no evidence of CNS disease progression For patients with previously untreated brain metastases, Central Nervous System (CNS) imaging is required at the time of disease imaging throughout treatment.
- At least one measurable disease site per RECIST v1.1.
- Received a minimum of one course of treatment that included at least one platinum-based chemotherapy doublet for metastatic or locally recurrent disease.
- Adequate hematologic function including ANC ≥ 1200/mm3, Hemoglobin ≥ 9 g/dL (transfusion is permitted), and platelets ≥ 100,000/mm3.
- Adequate hepatic function including ALT ≤ 2.5 x upper limit of normal (ULN) if liver metastasis is NOT present or ≤ 5 x ULN if liver metastasis is present, and total bilirubin ≤ 1.5 x ULN.
- QTc (corrected QT) interval < 480 msec.
Exclusion Criteria:
- Presence of an activating EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinase) translocation in the tumor.
- Radiotherapy (RT) completed within 14 days prior to the first dose of study therapy.
- Known impairment of gastrointestinal function that would alter drug absorption.
- Leptomeningeal metastasis.
- Symptomatic or untreated brain metastases or spinal cord compression or any of these conditions requiring chronic steroids to control symptoms.
- History or evidence of cardiac risk
- Known history of malignant hypertension (severe hypertension >180/120 mmHg with end organ involvement.
- Another active concurrent malignancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VS-6063 (defactinib)
Administered orally BID in a 21 day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Demonstrate that VS-6063 (defactinib), will improve PFS at 12 weeks (PFS12) within each cohort.
Time Frame: From baseline through 12 weeks of treatment
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From baseline through 12 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the response rate (RR)
Time Frame: Every 6 weeks from baseline through the end of treatment, an expected average of 4 months
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RR is measured as the best overall response using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1.
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Every 6 weeks from baseline through the end of treatment, an expected average of 4 months
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Evaluate progression free survival
Time Frame: From the date of first treatment to the date of progression including death from any cause, expected average at least 4 months
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PFS will be estimated in each cohort using Kaplan-Meier product limit estimates.
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From the date of first treatment to the date of progression including death from any cause, expected average at least 4 months
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Evaluate Overall Survival (OS)
Time Frame: OS will be calculated from the date of first treatment to the date of death from any cause, expected average of at least 12 months. Patients who did not experience death will be censored at the last follow-up time.
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OS in each cohort will be estimated using Kaplan-Meier product limit estimates.
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OS will be calculated from the date of first treatment to the date of death from any cause, expected average of at least 12 months. Patients who did not experience death will be censored at the last follow-up time.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the association between pharmacodynamic (PD) biomarkers and clinical outcomes (response rate, progression-free survival and overall survival)
Time Frame: Baseline PD biomarkers will be associated with the RR (collected every 6 weeks) and PFS, both with expected average of 4 months from first treatment to progression, and OS (expected average of 12 months from first treatment to date of death)
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Baseline PD biomarkers will be associated with the RR (collected every 6 weeks) and PFS, both with expected average of 4 months from first treatment to progression, and OS (expected average of 12 months from first treatment to date of death)
|
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Evaluate the safety and tolerability of VS-6063 (defactinib)
Time Frame: From start of treatment to end of treatment, an expected average of 4 months
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Adverse events (AEs) include the incidences of all treatment-emergent AEs (TEAEs) and all Serious Adverse Events (SAEs); by severity, relationship to study drug, and discontinuation of patients from study therapy due to AEs and due to deaths.
Safety endpoints for AEs, clinical laboratory tests, vital signs, ECGs and physical examinations will be summarized using descriptive statistics as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03
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From start of treatment to end of treatment, an expected average of 4 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David E Gerber, M.D., University of Texas Southwestern Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VS-6063-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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