A Phase 1, Open-Label, Dose-Ranging Study To Evaluate The Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously and as Different Oral Formulations In Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML), Lymphoma, and Multiple Myeloma(MM)
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation.
1 - 18 months
No
Barry Skikne, MD, FACP, FCP (SA)
Study Director
Celgene Corporation
United States: Food and Drug Administration
AZA PH US 2008 CL008
NCT00761722
September 2008
December 2013
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Northwest Cancer Specialists | Vancouver, Washington 98664 |
North Star Lodge Cancer Center | Yakima, Washington 98902 |
Kansas University Medical Center | Kansas City,, Kansas 66160-7390 |
Cancer Care Center of South Texas | San Antonio, Texas 78229 |