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A Phase II Study of MK-2206 in Patients With Advanced Hepatocellular Carcinoma Who Have Failed or Are Intolerant of One Prior Line of Anti-angiogenic Therapy
This phase II trial is studying how well MK2206 works in treating patients with advanced liver cancer that did not respond to previous therapy. MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Evaluate the median progression-free survival in patients with advanced hepatocellular carcinoma treated with MK-2206 after failure of one prior line of anti-angiogenic therapy. SECONDARY OBJECTIVES: I. Evaluate the objective response rate (CR + PR). II. Evaluate the median overall survival. III. Evaluate the tolerability and toxicity profile of MK-2206 in this patient population. IV. Explore, in a preliminary fashion, potential molecular predictors of efficacy. OUTLINE: Patients receive oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3-6 months thereafter.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Medical Center
Duarte, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Start Date
December 1, 2010
Primary Completion Date
February 1, 2013
Completion Date
February 1, 2013
Last Updated
October 5, 2015
15
ACTUAL participants
Akt Inhibitor MK2206
DRUG
Laboratory Biomarker Analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT02234986
NCT02024087
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01015833