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Brief Title: AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title: A Phase 2 Study of the AKT Kinase Inhibitor MK-2206 in Patients With Relapsed Refractory Acute Myelogenous Leukemia
Study ID: NCT01253447
Brief Summary: This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the proportion of patients achieving Morphologic Complete Response (CR), Morphologic CR with incomplete count recovery (CRp) or Partial Response (PR) as best response within 3 cycles of therapy with MK-2206. SECONDARY OBJECTIVES: I. Describe the disease-free survival of patients that achieve CR/CRp. II. Determine the toxicity profile of single-agent MK-2206 in this patient population. III. To determine the biologic effects of MK-2206 on leukemia cells. OUTLINE: Patients receive AKT inhibitor MK-2206 orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UT MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
Name: Marina Konopleva, MD, PHD
Affiliation: UT MD Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR