Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
Recruitment status was Active, not recruiting
This phase II clinical trial is studying how well selumetinib works in treating patients with recurrent or refractory acute myeloid leukemia. Selumetinib may stop the growth of cancer by blocking some of the enzymes needed for cell growth
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Promyelocytic Leukemia (M3)
Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
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 (CR, CR with incomplete count recovery, partial response, and minor response) to AZD6244 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]A Simon, optimal two-stage design will be employed in cohort A. For Cohort B, we will determine the response rate and provide an exact 90% confidence interval using the binomial distribution. The response rate in these patients will be compared to that observed in the main cohort using Fisherâs exact test.
- Response rates in patients with and without a mutation in RAS genes [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]Fisher's exact test will be utilized to compare response rates in those with and without a mutation in RAS genes.
- Changes in p-ERK [ Time Frame: From baseline to 1 month ] [ Designated as safety issue: No ]Wilcoxon nonparametric rank test will be utilized to assess changes in p-ERK from baseline to 1 week and baseline to 1 month.
|Study Start Date:||December 2007|
|Primary Completion Date:||December 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.
Other Names:Other: laboratory biomarker analysis
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|