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The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
| |
| Group 3 | Other | Control - participants with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onureg | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point | Day 1 | |
| AUC0-∞: Estimation of AUC calculated from time zero to infinity | Day 1 | |
| Cmax: Observed maximum concentration | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 9 Months | |
| Incidence of serious adverse events | Up to 9 Months | |
| Number of participants with clinically significant changes in electrocardiogram parameters |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0083 | Iowa City | Iowa | 52242 | United States | ||
| Local Institution - 0069 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Up to 9 Months |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 9 Months |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 9 Months |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 9 Months |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 9 Months |
| Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status | Up to 9 Months |
| Incidence of clinically significant changes in clinical laboratory results: Liver Function tests | Up to 9 Months |
| Number of clinically significant changes in physical examinations | Up to 9 Months |
| Number of participants with a recording of concomitant medications | Up to 9 Months |
| Number of participants with a recording of concomitant procedures | Up to 9 Months |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Local Institution | Cleveland | Ohio | 44106 | United States |
| Local Institution - 9003 | Charlottesville | Virginia | 22903 | United States |
| Local Institution - 0011 | Pilar | Buenos Aires | 1629 | Argentina |
| Local Institution - 0010 | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
| Local Institution - 0014 | Buenos Aires | Buenos Aires F.D. | C1118AAT | Argentina |
| Local Institution - 0012 | Buenos Aires | 1426 | Argentina |
| Local Institution - 0085 | Bogotá | Bogota D.C. | 110131 | Colombia |
| Local Institution - 0084 | Bogota | Cundinamarca | 111151 | Colombia |
| Local Institution - 0086 | Piedecuesta | Santander Department | 681017 | Colombia |
| Local Institution - 0076 | Augsburg | Bavaria | 86156 | Germany |
| Local Institution - 0075 | Halle | Saxony-Anhalt | 06120 | Germany |
| Local Institution - 0074 | Hamburg | 20246 | Germany |
| Local Institution - 0018 | Badalona | Barcelona [Barcelona] | 08916 | Spain |
| Local Institution - 0017 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Local Institution - 0015 | Pamplona | Navarre | 31008 | Spain |
| Local Institution - 0078 | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000709231 | cc-486 |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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