Clinical trialNCT00528983CompletedPhase 1Interventional

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia

SponsorCelgeneEnrollment133Acute Myelogenous Leukemia (AML)Chronic Myelomonocytic Leukemia (CMML)Myelodysplastic Syndromes (MDS)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to determine whether a tablet form of azacitidine that taken by mouth is safe. This Phase I study will also look at different doses and different treatment schedules in order to better understand the effects (positive and negative) of oral azacitidine on the body and on the disease MDS, AML and CMML.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Barry Skikne, M.D., FACP; FCP (SA)
Celgene Corporation
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Florida
Gainesville, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Kansas University Medical Center
Westwood, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Va Medical Center University of Kansas Medical Center
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology P.C.
Albany, New York, United States
Institute for Translational Oncology Research Irb
Greenville, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology Cancer Care
Austin, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Hoast
San Antonio, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azacitidine →Subcutaneous Azacitidine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Sept 2007
Primary completion: 31 Jul 2013
Completion: 5 Apr 2016
Last update posted: 8 Nov 2019
Registered enrollment: 133
Registry id: NCT00528983

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.