Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase 2 Study of AZD6244 in Relapsed or Refractory AML
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
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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