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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05209295
Collaborator
(none)
32
Enrollment
2
Locations
3
Arms
30.7
Anticipated Duration (Months)
16
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-486 (Onureg®) in Subjects With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Adult Cancer Subjects
Anticipated Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Drug: Onureg
Specified dose on specified days
Other Names:
  • CC-486, Oral Azacitidine

    • Drug: Vidaza
    Specified dose on specified days
    Other Names:
  • CC-486, Intravenous/Subcutaneous Azacitidine

    		•
    Experimental: Group 2

    Drug: Onureg
    Specified dose on specified days
    Other Names:
  • CC-486, Oral Azacitidine

    • Drug: Vidaza
    Specified dose on specified days
    Other Names:
  • CC-486, Intravenous/Subcutaneous Azacitidine

    		•
    Other: Group 3

    Control - participants with normal hepatic function

    Drug: Onureg
    Specified dose on specified days
    Other Names:
  • CC-486, Oral Azacitidine

    • Drug: Vidaza
    Specified dose on specified days
    Other Names:
  • CC-486, Intravenous/Subcutaneous Azacitidine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point [Day 1]

    2. AUC0-∞: Estimation of AUC calculated from time zero to infinity [Day 1]

    3. Cmax: Estimation of observed maximum concentration [Day 1]

    Secondary Outcome Measures

    1. Incidence of adverse events [Up to 9 Months]

    2. Incidence of serious adverse events [Up to 9 Months]

    3. Number of participants with clinically significant changes in electrocardiogram parameters [Up to 9 Months]

    4. Incidence of clinically significant changes in vital signs: Body temperature [Up to 9 Months]

    5. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 9 Months]

    6. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 9 Months]

    7. Incidence of clinically significant changes in vital signs: Heart rate [Up to 9 Months]

    8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 9 Months]

    9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 9 Months]

    10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 9 Months]

    11. Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status [Up to 9 Months]

    12. Incidence of clinically significant changes in clinical laboratory results: Liver Function tests [Up to 9 Months]

    13. Number of clinically significant changes in physical examinations [Up to 9 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Port Jefferson Station New York United States 11776
    2 Local Institution Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05209295
    Other Study ID Numbers:
    • CA055-001
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    CC-486
    Azacitidine
    Hepatic Impairment
    Additional relevant MeSH terms:
    Hepatic Insufficiency
    Liver Failure
    Azacitidine
    Cc-486

    Study Results

    No Results Posted as of Jan 26, 2022