Clinical Trials Directory

Trials / Completed

CompletedNCT00451048

Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

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

Summary

This phase II trial is studying how well sunitinib works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth.

Detailed description

OBJECTIVES: 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.

Conditions

Interventions

TypeNameDescription
DRUGsunitinib malateGiven orally

Timeline

Start date
2007-02-01
Primary completion
2011-09-01
Completion
2012-10-01
First posted
2007-03-22
Last updated
2018-09-04
Results posted
2014-09-01

Locations

4 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00451048. Inclusion in this directory is not an endorsement.