A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers
I. To evaluate the objective response rate (complete and partial response), as defined by
the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, in patients with
advanced refractory biliary cancers (BC) receiving Akt inhibitor MK2206 (MK2206).
I. To determine the frequency and severity of adverse events and tolerability of the regimen
in patients with advanced refractory BC receiving MK2206.
II. To determine the overall and progression-free survival of patients with advanced
refractory BC receiving MK2206.
III. To determine the presence of genetic mutations of PI3-kinase/ Akt pathway
signaling-pathway genes relevant to BC and how these correlate with objective response to
treatment with MK2206.
IV. To determine the pharmacokinetic and pharmacogenetic profile as a way of assessing
inter-individual variability as well as how these relate to clinical outcomes.
V. To determine genetic variants and mutations in genes encoding drug-metabolizing enzymes
and transporters, and genes involved in tumor biology, and how these may be related to
response to treatment.
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for pharmacokinetic,
pharmacogenetic, and other correlative studies. Previously collected tumor tissue is also
After completion of study therapy, patients are followed up for 4 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial response) as defined by RECIST 1.1
Up to 4 weeks after completion of study treatment
Ohio State University
United States: Food and Drug Administration
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Emory University||Atlanta, Georgia 30322|
|Ohio State University Medical Center||Columbus, Ohio 43210|
|M D Anderson Cancer Center||Houston, Texas 77030|
|University of Southern California||Los Angeles, California 90033|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|
|Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106|