NCT01425879

MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery

A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (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 MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.

Detailed description

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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 analyzed. After completion of study therapy, patients are followed up for 4 weeks.

Conditions

• Advanced Adult Hepatocellular Carcinoma
• Localized Non-Resectable Adult Liver Carcinoma
• Recurrent Adult Liver Carcinoma
• Recurrent Gallbladder Carcinoma
• Stage IV Distal Bile Duct Cancer
• Stage IV Gallbladder Cancer
• Unresectable Extrahepatic Bile Duct Carcinoma
• Unresectable Gallbladder Carcinoma

Interventions

Type	Name	Description
DRUG	Akt Inhibitor MK2206	Given PO
OTHER	Diagnostic Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-05-01
• Completion: 2014-05-01
• First posted: 2011-08-30
• Last updated: 2016-06-17
• Results posted: 2016-04-15

Locations

8 sites across 1 country: United States