A Phase II Study of AZD2171 in the Treatment of Patients With Acute Leukemia and Myelodysplastic Syndrome
I. Evaluate the objective response rate in patients with relapsed, refractory, or untreated
acute myeloid leukemia or high-risk myelodysplastic syndromes treated with AZD2171
I. Determine the toxicity of this drug in these patients. II. Determine the response
duration, event-free survival, and overall survival of patients treated with this drug.
III. Determine the hematological response rate in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (acute
myeloid leukemia vs myelodysplastic syndromes).
Patients receive oral cediranib maleate once daily (QD) on days 1-28. Treatment repeats
every 28 days for up to 26 courses in the absence of disease progression or unacceptable
toxicity. Patients undergo bone marrow biopsy at baseline and on day 28 for correlative
studies. Samples are analyzed for circulating endothelial cells, VEGF receptor expression,
and leukemic blasts via flow cytometry and microvessel density via histopathological
After completion of study treatment, patients are followed up at 3 months and then every 6
months for up to 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed disease response
Defined to be an objective status of CR, PR or HI noted on 2 consecutive evaluations.
At the end of courses 1 and 3 and every 3 courses thereafter
United States: Food and Drug Administration
|Howard University Hospital||Washington, District of Columbia 20060|
|Johns Hopkins University||Baltimore, Maryland 21205|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|
|Wayne State University||Detroit, Michigan 48202|