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The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral azacitidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral azacitidine | Drug | Patients will receive 300 mg dose of oral azacitidine administered once daily for the first 21 days of each 28-day treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| PK- Maximum concentration in plasma (Cmax) | PK- Maximum concentration in plasma (Cmax) | 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) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Masamitsu Harata | Celgene K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celgene Trial Site | Fukuoka | Japan | ||||
| Celgene Trial Site |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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PK- Time to maximum plasma concentration (Tmax)
| 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) | 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) | 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) | 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) | 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) | 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) | Up to 2 years |
| Efficacy (Hematologic response and hematologic improvement) | Efficacy (Hematologic response and hematologic improvement) | Up to 2 years |
| Hiroshima |
| Japan |
| Celgene Trial Site | Nagoya | Japan |
| Celgene Trial Site | Osaka | Japan |
| Celgene Trial Site | Tokyo | Japan |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |