NCT00588809

Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

A Phase 2 Study of AZD6244 in Relapsed or Refractory AML

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	selumetinib	Given PO

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-04-01
• Completion: 2012-12-01
• First posted: 2008-01-09
• Last updated: 2015-08-05
• Results posted: 2015-08-05

Locations

1 site across 1 country: United States