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Leukemia

Oral Azacitidine for MDS, CMML and AML (2474)
A Phase I, Open-Label, Dose-Escalation Study to Evaluate The Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML).
Status Conditions Phase Study ID
Closed Myelodysplastic Syndromes (MDS);
Chronic Myelomonocytic Leukemia (CMML);
Acute Myelogenous Leukemia (AML)
Phase I 2474.00
NCT00528983
Summary

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.


Investigator
Bart Scott, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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.
Exclusions (conditions that would prevent participation in this study)
  • 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.
Last Updated
July 25, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.