Myelodysplastic Syndromes (MDS) Clinical Trial
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).
Verified date | November 2019 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | April 5, 2016 |
Est. primary completion date | July 31, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | New York Oncology Hematology P.C. | Albany | New York |
United States | Texas Oncology Cancer Care | Austin | Texas |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Gabrail Cancer Center | Canton | Ohio |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | University of Florida | Gainesville | Florida |
United States | Institute for Translational Oncology Research IRB | Greenville | North Carolina |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Central Indiana Cancer Centers | Indianapolis | Indiana |
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 | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | HOAST | San Antonio | Texas |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Kansas University Medical Center | Westwood | Kansas |
United States | Yakima Valley Memorial Hospital/ North Star Lodge | Yakima | Washington |
Lead Sponsor | Collaborator |
---|---|
Celgene |
United States,
Garcia-Manero G, Gore SD, Cogle C, Ward R, Shi T, Macbeth KJ, Laille E, Giordano H, Sakoian S, Jabbour E, Kantarjian H, Skikne B. Phase I study of oral azacitidine in myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia. J Clin Oncol. 2011 Jun 20;29(18):2521-7. doi: 10.1200/JCO.2010.34.4226. Epub 2011 May 16. — View Citation
Garcia-Manero G, Gore SD, Kambhampati S, Scott B, Tefferi A, Cogle CR, Edenfield WJ, Hetzer J, Kumar K, Laille E, Shi T, MacBeth KJ, Skikne B. Efficacy and safety of extended dosing schedules of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes. Leukemia. 2016 Apr;30(4):889-96. doi: 10.1038/leu.2015.265. Epub 2015 Oct 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety evaluation as measured by monitoring AEs, dose limiting toxicities, scheduled lab assessments, vital sign measurements, ECGs, & physical exams for study duration. Adverse changes in physical signs/symptoms will be graded according to CTC AE V.3.0. | 60 months | ||
Primary | Maximum-tolerated dose | 60 months | ||
Primary | Pharmacodynamic blood and bone marrow samples will be collected and evaluated. | 60 months | ||
Secondary | Efficacy assessed by evidence of response (MDS subjects) and/or hematologic improvement (MDS subjects) examined using IWG criteria. | 60 months | ||
Secondary | Biologically active dose based on safety, PK and PD data. | 60 months |
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