NCT01085214

AZD6244 (Selumetinib) in Treating Patients With Multiple Myeloma

A Phase 2 Study of AZD6244 in Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.

Detailed description

PRIMARY OBJECTIVES: I. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in patients with relapsed or refractory multiple myeloma (MM). SECONDARY OBJECTIVES: I. To evaluate the toxicity of AZD6244 in patients with MM. II. To estimate progression-free survival and duration of response to AZD6244. III. To test whether AZD6244 hydrogen sulfate capsules downregulate tumor cell phosphorylated mitogen-activated protein kinase (pERK)1/2. OUTLINE: Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 weeks.

Conditions

• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Selumetinib	AZD6244 (Selumetinib), 75 mg was administered orally, twice a day, continuously for 28-day cycles

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-03-11
• Last updated: 2015-08-19
• Results posted: 2015-08-19

Locations

9 sites across 1 country: United States