GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer
|ClinicalTrials.gov Identifier: NCT01553851|
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : December 26, 2016
Last Update Posted : December 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms, Oral Mouth Neoplasms||Drug: GSK1120212||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Window of Opportunity Trial With GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||December 2015|
GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
- Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212. [ Time Frame: Baseline and Day 15 ]Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.
- Number of Participants With Changes in TumorCell Surface CD44 Expression After Treatment With GSK1120212. [ Time Frame: Baseline and Day 15 ]Pre-post measure of CD44 expression using IHC.
- Tumor Specific Findings for Pathologic Changes Including Proliferation (Ki-67 Staining), Tumor Vasculature Staining (Microvessel Density), ERK1/2 Mediated Changes in p27 (Kip1) & Flow Cytometric Analysis of the Peripheral Blood & Tumor. [ Time Frame: Baseline and Day 15 ]
- Percentage of Participants With Clinical Response Induced by GSK1120212, as Determined by Change in Tumor Size. [ Time Frame: Baseline and Day 15 ]Clinical Response was evaluted by quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.
- Flow Cytometric Analysis of the Peripheral Blood and Tumor. [ Time Frame: Baseline, Day 14, and Day 15 ]
Peripheral blood - baseline and Day 14
Tumor - baseline and Day 15
- Percent Change in Maximum Standard Uptake Value in Oral Cavity Saqumous Cell Carcinoma (OCSCC) Using F18-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT). [ Time Frame: Baseline and Day 14 ]
- Safety of GSK1120212 [ Time Frame: 1st 4-6 week follow-up visit ]Number of adverse events were monitored for 30 day following last dose of GSK1120212
- Percent Change in Tumor Size Area [ Time Frame: Baseline and Day 15 ]
- Percent of Participants With Metabolic Changes in OCSCC Using FDG-PET/CT Imaging. [ Time Frame: Baseline and Day 14 ]Intratumarol metabolic changes were evaluated by changes in in SUVmax in the primary tumor; quantitative analysis SUVmax with the primary tumor site was determined within a volume of interest around the tumor using a Siemens eSoft workstation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553851
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Douglas Adkins, M.D.||Washington University School of Medicine|