Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia|
- Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: No ]
- Progression-free Survival [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: No ]
- Frequency and Severity of Observed Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients will receive sunitinib malate (SU11248) by mouth once a day. Treatment may continue for as long as benefit is shown.
Drug: sunitinib malate
I. Determine the overall response rate (complete response, partial response, or hematological improvement) in patients with intermediate-2 or high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia treated with sunitinib malate.
II. Determine the duration of response in patients treated with this drug. III. Determine the overall survival of patients treated with this drug. IV. Determine the progression-free survival of patients treated with this drug. V. Determine the time to disease progression in patients treated with this drug.
VI. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3-4 weeks and then monthly thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451048
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Odette Cancer Centre- Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Karen Yee||University Health Network-Princess Margaret Hospital|