A Phase 1 interventional study of Oral azacitidine in Myelodysplastic Syndromes, sponsored by Celgene. Completed at 5 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Celgene · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 5 is below the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
The presence of any of the following will exclude a patient from enrollment:
Drug: Oral azacitidine
Patients will receive 300 mg dose of oral azacitidine administered once daily for the first 21 days of each 28-day treatment cycle.
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
Time frame: 1 month
PK- Maximum concentration in plasma (Cmax)
PK- Maximum concentration in plasma (Cmax)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
PK- Time to maximum plasma concentration (Tmax)
PK- Time to maximum plasma concentration (Tmax)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
PK-Elimination rate constant (Kel)
PK-Elimination rate constant (Kel)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
PK-Terminal half-life (T1/2,z)
PK-Terminal half-life (T1/2,z)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
PK-Area under the plasma concentration-time curve (AUC)
PK-Area under the plasma concentration-time curve (AUC)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
PK-Apparent total body clearance (CL/F)
PK-Apparent total body clearance (CL/F)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
PK-Apparent volume of distribution (Vz/f)
PK-Apparent volume of distribution (Vz/f)
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Safety (type, frequency, severity, number of participants with adverse events)
Safety (type, frequency, severity, number of participants with adverse events)
Time frame: Up to 2 years
Efficacy (Hematologic response and hematologic improvement)
Efficacy (Hematologic response and hematologic improvement)
Time frame: Up to 2 years
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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