GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||June 2015|
|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.
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): 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|