Spots Global Cancer Trial Database for Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine
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Trial Identification
Brief Title: Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine
Official Title: A PHASE 1, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND EFFECT OF FOOD OF A NEW TABLET FORMULATION OF ORAL AZACITIDINE, AND TO EVALUATE THE SAFETY AND EFFICACY OF ORAL AZACITIDINE IN SUBJECTS WITH MYELODYSPLASTIC SYNDROMES, CHRONIC MYELOMONOCYTIC LEUKEMIA OR ACUTE MYELOID LEUKEMIA
Study ID: NCT01519011
Study Description
Brief Summary: The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg tablets relative to three 100-mg tablets.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores UCSD Cancer Center MC-0987, La Jolla, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
University of Cincinnati Physician's Inc., Cincinnati, Ohio, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Texas Oncology, Dallas, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Contact Details
Name: Barry Skikne, M.D.
Affiliation: Celgene
Role: STUDY_DIRECTOR
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