Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Promyelocytic Leukemia (M3)
Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD6244 in Relapsed or Refractory AML|
- Response Rate for Subjects Without FLT3 ITD Mutation [ Time Frame: Up to 52 weeks ]
Responses were defined using standard criteria developed by an International Working Group.
[Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642-9.]
In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR).
- Proportion of Subjects With Baseline p-ERK Activation [ Time Frame: baseline (0 weeks) ]Proportion of subjects with baseline p-ERK activation
- Proportion of Subjects With NRAS Mutation [ Time Frame: baseline (0 weeks) ]Proportion of Subjects With NRAS Mutation
- Proportion of Subjects With KRAS Mutation [ Time Frame: baseline (0 weeks) ]Proportion of subjects with KRAS mutation
- Proportion of Subjects With FLT3 ITD Mutation [ Time Frame: baseline (0 weeks) ]Proportion of subjects with FLT3 ITD mutation
- Proportion of Subjects With KIT Mutation [ Time Frame: baseline (0 weeks) ]Proportion of subjects with KIT mutation
|Study Start Date:||December 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment (selumetinib)
Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
I. To determine the response rate (includes complete response-CR, complete response with incomplete count recovery CRi, partial response-PR, and minor response-MR) to AZD6244 (selumetinib).
I. To determine the effects of AZD6244 in AML samples on p-ERK and evaluate the potential utility of p-ERK inhibition as a surrogate marker of biologic activity.
II. To correlate the effects of AZD6244 with the presence (or absence) of mutated RAS or FLT-3 at baseline.
III. To assess the safety profile of AZD6244 in patients with AML.
Patients receive selumetinib orally (PO) twice daily (BID) on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 52 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588809
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Olatoyosi Odenike||University of Chicago Comprehensive Cancer Center|