Phase II Study of VS-6063 in Patients With KRAS Mutant Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01951690|
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : April 13, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Lung Cancer||Drug: defactinib (VS-6063)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: VS-6063 (defactinib)
Administered orally BID in a 21 day cycle
Drug: defactinib (VS-6063)
- Demonstrate that VS-6063 (defactinib), will improve PFS at 12 weeks (PFS12) within each cohort. [ Time Frame: From baseline through 12 weeks of treatment ]
- Evaluate the response rate (RR) [ Time Frame: Every 6 weeks from baseline through the end of treatment, an expected average of 4 months ]RR is measured as the best overall response using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1.
- 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 ]PFS will be estimated in each cohort using Kaplan-Meier product limit estimates.
- 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. ]OS in each cohort will be estimated using Kaplan-Meier product limit estimates.
- 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) ]
- 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 ]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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- ≥ 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951690
|United States, Colorado|
|University of Colorado Cancer Center, Anschutz Medical Campus|
|Denver, Colorado, United States, 80045|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, Oregon|
|Knight Cancer Institute, Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390-8852|
|The University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||David E Gerber, M.D.||University of Texas Southwestern Medical Center|
|Responsible Party:||Verastem, Inc.|
|Other Study ID Numbers:||
|First Posted:||September 27, 2013 Key Record Dates|
|Last Update Posted:||April 13, 2017|
|Last Verified:||April 2017|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Focal Adhesion Kinase inhibitor
Cancer Stem Cells
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases