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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209295
• Other study ID #: CA055-001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 31, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure
• Neoplasms

Intervention

Drug:
• Onureg
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	ABB	Ciudad Autónoma De Buenos Aires
Argentina	Clínica Zabala	Buenos Aires
Argentina	Hospital Aleman	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0011	Pilar	Buenos Aires
Colombia	Local Institution - 0084	Bogota	Cundinamarca
Colombia	Local Institution - 0085	Bogotá	Distrito Capital De Bogotá
Colombia	Local Institution - 0086	Piedecuesta	Santander
Germany	Klinikum Augsburg	Augsburg	Bayern
Germany	Local Institution - 0075	Halle	Sachsen-Anhalt
Germany	Local Institution - 0074	Hamburg
Greece	Local Institution - 9000	Thessaloniki
Spain	Local Institution - 0018	Badalona	Barcelona [Barcelona]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Local Institution - 0078	Salamanca
United States	Local Institution - 9003	Charlottesville	Virginia
United States	Local Institution	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Iowa	Iowa City	Iowa
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Local Institution - 0007	Port Jefferson Station	New York
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Germany,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point		Day 1
Primary	AUC0-8: Estimation of AUC calculated from time zero to infinity		Day 1
Primary	Cmax: Observed maximum concentration		Day 1
Secondary	Incidence of adverse events		Up to 9 Months
Secondary	Incidence of serious adverse events		Up to 9 Months
Secondary	Number of participants with clinically significant changes in electrocardiogram parameters		Up to 9 Months
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 9 Months
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 9 Months
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 9 Months
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 9 Months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 9 Months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 9 Months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 9 Months
Secondary	Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status		Up to 9 Months
Secondary	Incidence of clinically significant changes in clinical laboratory results: Liver Function tests		Up to 9 Months
Secondary	Number of clinically significant changes in physical examinations		Up to 9 Months
Secondary	Number of participants with a recording of concomitant medications		Up to 9 Months
Secondary	Number of participants with a recording of concomitant procedures		Up to 9 Months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting