Selumetinib in Treating Patients With Multiple Myeloma
The purpose of this study is to find out what effects, good and/or bad, AZD6244 has on participants and their multiple myeloma. In some types of cancer such as myeloma, a protein called MEK is overactive. This protein is important for cancer cells to be able to reproduce and survive. Because AZD6244 prevents MEK from working properly, it may keep cancer cells from growing and living, so cancer may shrink or its growth may slow down. There is no guarantee, however, that this will happen to the patient's cancer if they join this study.
Refractory Multiple Myeloma
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 Multiple Myeloma|
- Overall response (sCR+CR++VGPR+PR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Toxicity, graded using the NCI CTCAE [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Tabulated by category and grade.
- Progression-free survival [ Time Frame: From registration to progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Duration of response [ Time Frame: From response to disease progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
|Study Start Date:||March 2010|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (selumetinib)
Patients receive selumetinib orally BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
I. To assess the response rate of AZD6244 hydrogen sulfate capsules in patients with relapsed or refractory MM.
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 pERK1/2.
Patients receive selumetinib orally 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.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|National Institutes of Health|
|Bethesda, Maryland, United States, 20892|
|United States, Montana|
|Billings, Montana, United States, 59107-7000|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Steven Grant||H. Lee Moffitt Cancer Center and Research Institute|