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

TerminadoFase 1ClinicalTrials.gov

ID: NCT05209295Tipo: INTERVENTIONALInicio: 12 de jul de 2024Fin estimado: 20 de abr de 2025

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Onureg

Specified dose on specified days

Ubicaciones

Local Institution - 0011

Pilar, Buenos Aires, Argentina

Local Institution - 0010

ABB, Buenos Aires F.D., Argentina

Local Institution - 0014

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0012

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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