Study Stopped
Early termination for discouraging results
MK2206 in Treating Patients With Advanced Liver Cancer That Did Not Respond to Previous Therapy
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
7 other identifiers
interventional
15
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2010
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
October 5, 2015
CompletedOctober 5, 2015
March 1, 2013
2.2 years
November 10, 2010
June 10, 2015
September 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Until disease progression or death, up to 26 months
Secondary Outcomes (2)
Objective Response
Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months
Overall Survival
Until death, up to 26 months
Study Arms (1)
Treatment (Akt inhibitor MK2206)
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Unresectable or metastatic HCC for which standard curative measures do not exist
- The diagnosis of hepatocellular carcinoma should be based on at least one of the following:
- The presence of one or more liver lesions, measuring \>= 2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection
- The presence of liver lesion(s) with AFP \>= 400
- Tissue confirmation in the absence of either or both of the above
- Tissue availability is desired and will be sought, but tissue availability is not mandated for accrual to the study
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension, and that has not been the target of local or regional therapy including transarterial chemoembolization, intra-arterial chemotherapy, ethanol, or RFA ablation
- One prior line of systemic anti-angiogenic therapy is required; this type of therapy includes, but is not restricted to, sorafenib, bevacizumab, sunitinib, or brivanib given as single agents or in combination with other agents
- No clinically evident ascites (minimal, medically controlled ascites detectable on imaging studies only is allowed)
- No Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
- No fibrolamellar carcinoma or any mixed variants of HCC with dominant fibrolamellar histology
- Patients with known brain metastases should be excluded from this clinical trial
- ECOG 0-1
- Life expectancy of greater than 3 months
- Leukocytes \>= 3,000/mcL
- +43 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
City of Hope Medical Center
Duarte, California, 91010, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results
Results Point of Contact
- Title
- DCC Project Administrator
- Organization
- California Cancer Consortium
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony El-Khoueiry, MD
University of Southern California, Norris
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2010
First Posted
November 11, 2010
Study Start
December 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
October 5, 2015
Results First Posted
October 5, 2015
Record last verified: 2013-03