A Study to Evaluate CC-486 in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Cancer Participants

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of moderate and severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in adult cancer participants. This study will also evaluate the safety and tolerability of intravenous/subcutaneous azacitidine in adult cancer participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Azacitidine; Cc-486

Criteria

Inclusion Criteria:

• Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Multiple myeloma, Non-Hodgkin's lymphoma, Hodgkin's lymphoma or metastatic or inoperable solid tumors

• 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 Criteria:

• Chemotherapy or radiotherapy within 4 weeks 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