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Not Yet Recruiting

A Study to Evaluate CC-486 in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Cancer Participants - CA055-001

Updated: 13 January, 2022   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 1

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Group 1
Drug: Onureg Drug: Vidaza
Experimental: Group 2
Drug: Onureg Drug: Vidaza
Other: Group 3
Drug: Onureg Drug: Vidaza

Key Eligibility Criteria

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

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com