Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer



Status:Archived
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2010
End Date:March 2012

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A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK Inhibitor GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Subjects With Metastatic Pancreatic Cancer


GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase
activity and has demonstrated potent anti-proliferative activity against human pancreatic
cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK
inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with
metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with
oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria
are met. The primary objective will be to compare the overall survival of subjects in the
GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary
objectives include comparison of progression free survival, overall response rate, and
duration of response between the two arms. Exploratory research objectives include the
evaluation of population pharmacokinetics as well as blood and tissue based biomarkers.
Safety will also be monitored throughout dosing.

Once the determined number of survival events has occurred, if subjects are eligible, they
will have the option to enter MEK114375, an open-label, Phase Ib rollover study of
GSK1120212 monotherapy or GSK1120212 in combination with other anti-cancer treatments.



We found this trial at
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4000 Reservoir Road NW, Suite 120
Washington, Washington DC 20007
(202) 687-0100
Georgetown Univ Med Ctr Georgetown University Medical Center is committed to excellence in research, education...
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Austin, Texas 78705
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Baton Rouge, Louisiana 70809
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Charleston, South Carolina 29425
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Indianapolis, Indiana 46202
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Kennewick, Washington 99336
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Knoxville, Tennessee 37916
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Las Vegas, Nevada 89102
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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New Haven, Connecticut 06520
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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Philadelphia, Pennsylvania 19104
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Richmond, Virginia 23298
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Roswell, Georgia 30076
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