AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia. AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Recurrent Adult Acute Myeloid Leukemia
Drug: Akt inhibitor MK2206
Other: laboratory biomarker analysis
Genetic: protein expression analysis
Other: flow cytometry
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of the AKT Kinase Inhibitor MK-2206 in Patients With Relapsed Refractory Acute Myelogenous Leukemia|
- Response rate defined as CR, CRp, or PR [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]Response rates will be estimated with 95% confidence intervals, for all subjects and for patient subgroups defined by disease characteristics at registration. The association between response and patient characteristics will be examined by Wilcoxon rank sum test or Fisher Exact test. Disease free survival will be estimated using Kaplan Meier method.
- Treatment-related non-hematological toxicity [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)
- Maximum percentage change in apoptosis [ Time Frame: Baseline to 12 courses ] [ Designated as safety issue: No ]The two-sample t-test will be conducted to compare the changes between the responders and non-responders.
|Study Start Date:||October 2010|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive Akt inhibitor MK2206 PO once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206
Other Name: MK2206Other: laboratory biomarker analysis
Correlative studiesGenetic: protein expression analysis
Correlative studiesOther: flow cytometry
I. Determine the proportion of patients achieving CR, CRp or PR as best response within 3 cycles of therapy with MK-2206.
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.
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.
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Marina Konopleva||M.D. Anderson Cancer Center|