Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatic Insufficiency
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acute promyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negative myeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasms overlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blastic plasmacytoid dendritic cell neoplasm according to the World Health Organization (WHO) 2016 classification
- Life expectancy of ≥ 3 months
- Stable renal function without dialysis for at least 2 months prior to investigational product administration
- Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria
Exclusion
- Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first day of investigational product administration
- Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to \< Grade 2
- Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study
- History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
July 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05209295
Start Date
July 12 2024
End Date
June 30 2025
Last Update
June 24 2025
Active Locations (18)
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1
Local Institution - 0083
Iowa City, Iowa, United States, 52242
2
Local Institution - 0069
Detroit, Michigan, United States, 48202
3
Local Institution
Cleveland, Ohio, United States, 44106
4
Local Institution - 9003
Charlottesville, Virginia, United States, 22903