Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia
Public ClinicalTrials.gov record NCT00528983. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 1, Open-label, Dose-Escalation Trial 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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00528983
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 133 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 11, 2007 (Actual)
- Primary completion
- Jul 31, 2013 (Actual)
- Completion
- Apr 5, 2016 (Actual)
- Last update posted
- Nov 8, 2019
2007 – 2016
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610-0277 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Central Indiana Cancer Centers | Indianapolis | Indiana | 46219 | — |
| Kansas University Medical Center | Westwood | Kansas | 66205 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231-1000 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Kansas City VA Medical Center University of Kansas Medical Center | Kansas City | Missouri | 64128 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| New York Oncology Hematology P.C. | Albany | New York | 12206 | — |
| Institute for Translational Oncology Research IRB | Greenville | North Carolina | 29605 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology Cancer Care | Austin | Texas | 78731 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| HOAST | San Antonio | Texas | 78229 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-4417 | — |
| Yakima Valley Memorial Hospital/ North Star Lodge | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00528983, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 8, 2019 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00528983 live on ClinicalTrials.gov.