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The trial is taking place at:
U

University of Massachusetts Chan Medical School | Medicine Department - Rheumatology Division

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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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 1

Conditions

Neoplasms
Hepatic Insufficiency

Treatments

Drug: Onureg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05209295
CA055-001

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 3 patient groups

Group 1
Experimental group
Treatment:
Drug: Onureg
Group 2
Experimental group
Treatment:
Drug: Onureg
Group 3
Other group
Description:
Control - participants with normal hepatic function
Treatment:
Drug: Onureg

Trial contacts and locations

22

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Central trial contact

First line of the email MUST contain the NCT# and the Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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