Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00451048|
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : September 1, 2014
Last Update Posted : September 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes||Drug: sunitinib malate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||October 2012|
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
- Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria [ Time Frame: Up to 6 years ]
- Number Participants With Complete, Partial or Hematologic Improvement Response [ Time Frame: Up to 6 years ]Assessed by achievement of Complete Response (CR), Partial Response (PR) or Hematologic Improvement (HI)
- Overall Survival [ Time Frame: At 6 months and 1 year ]
- Progression-free Survival [ Time Frame: At 6 months and 1 year ]
- Time to Progression [ Time Frame: At 6 months and 1 year ]
- Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0) [ Time Frame: Up to 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|