Clinical Trials Directory

Trials / Terminated

TerminatedNCT01239355

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
15 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGAkt Inhibitor MK2206Given PO
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2010-12-01
Primary completion
2013-02-01
Completion
2013-02-01
First posted
2010-11-11
Last updated
2015-10-05
Results posted
2015-10-05

Locations

22 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01239355. Inclusion in this directory is not an endorsement.