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

Completed · Phase 1

Conditions studied: Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT00528983

Run by

Celgene

People needed

133

Starts

2007-09-11

Expected to finish

2016-04-05

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older.
• Diagnosis of low or Int-1 risk MDS
• Low platelet count, and/or low hemoglobin, and/or RBC transfusion-dependent and/or platelet transfusion-dependent
• ECOG Performance status 0-2
• Standard safety inclusion for serum creatinine, AST, ALT, bilirubin.
• Serum bicarbonate greater than or equal to 20 mEq/L.
• Use of acceptable birth control.
• Signed, written informed consent.

You may not qualify if…

• Diagnosis of acute PML.
• Previous or concurrent malignancy.
• Prior treatment with azacitidine or other demethylating agents.
• Treatment with any anticancer therapy or investigational drugs within 21 days.
• Hypersensitivity to azacitidine or mannitol.
• Presence of GI disease.
• Active, uncontrolled infection.
• Known Human Immunodeficiency Virus (HIV) or Hepatitis C, or known active viral Hepatitis B.
• Breastfeeding or Pregnant females;
• Presence of serious illness, medical condition, or other medical history which would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
• Current congestive heart failure (NY Heart Association Class III-IV), unstable angina or angina requiring surgical or medical intervention within 6 months, myocardial infarct within 6 months, or uncontrolled cardiac arrhythmia.

Where it is running

• 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

Full record on ClinicalTrials.gov

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