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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

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ClinicalTrials.gov Identifier: NCT05209295
Recruitment Status : Recruiting
First Posted : January 26, 2022
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 with myeloid malignancies.

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Neoplasms Drug: Onureg Phase 1

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 Subjects With Myeloid Malignancies
Estimated Study Start Date : May 24, 2024
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 Drug: Onureg
Specified dose on specified days
Other Name: CC-486, Oral Azacitidine
Experimental: Group 2 Drug: Onureg
Specified dose on specified days
Other Name: CC-486, Oral Azacitidine
Group 3
Control - participants with normal hepatic function
 Drug: Onureg
Specified dose on specified days
Other Name: CC-486, Oral Azacitidine


Outcome Measures
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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 [ Time Frame: Day 1 ]
  2. AUC0-∞: Estimation of AUC calculated from time zero to infinity [ Time Frame: Day 1 ]
  3. Cmax: Observed maximum concentration [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 9 Months ]
  2. Incidence of serious adverse events [ Time Frame: Up to 9 Months ]
  3. Number of participants with clinically significant changes in electrocardiogram parameters [ Time Frame: Up to 9 Months ]
  4. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 9 Months ]
  5. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 9 Months ]
  6. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 9 Months ]
  7. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 9 Months ]
  8. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 9 Months ]
  9. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 9 Months ]
  10. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 9 Months ]
  11. Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 9 Months ]
  12. Incidence of clinically significant changes in clinical laboratory results: Liver Function tests [ Time Frame: Up to 9 Months ]
  13. Number of clinically significant changes in physical examinations [ Time Frame: Up to 9 Months ]
  14. Number of participants with a recording of concomitant medications [ Time Frame: Up to 9 Months ]
  15. Number of participants with a recording of concomitant procedures [ Time Frame: Up to 9 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209295


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and the Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05209295    
Other Study ID Numbers: CA055-001
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024

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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
Onureg
Myeloid Malignancies
Additional relevant MeSH terms:
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Neoplasms
Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases
Azacitidine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors