Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00588809|
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : August 5, 2015
Last Update Posted : August 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Promyelocytic Leukemia (M3) Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Recurrent Adult Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia||Drug: selumetinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of AZD6244 in Relapsed or Refractory AML|
|Study Start Date :||December 2007|
|Primary Completion Date :||April 2012|
|Study Completion Date :||December 2012|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|