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Anti-metabolites

Onureg for Cancer in Liver Failure

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria

Must not have

Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to < Grade 2

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial will test the effects of azacitidine on adults with cancer and liver impairment. It will also study the safety and feasibility of giving azacitidine intravenously or subcutaneously.

Who is the study for?

This trial is for people with certain blood cancers or inoperable tumors who also have moderate to severe liver problems. They should be expected to live at least 3 more months and not need dialysis. People can't join if they're still dealing with serious side effects from past treatments, have gut diseases that could affect drug absorption, or had chemo/radiotherapy within the last month.

What is being tested?

The study tests how liver impairment affects Onureg (oral azacitidine) levels in the body and its safety for those with myeloid malignancies. It aims to understand if and how liver function changes the way this cancer medication works.

What are the potential side effects?

While specific side effects of Onureg are not listed here, common ones may include nausea, vomiting, diarrhea, fatigue, and low blood cell counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific blood cancer as per WHO 2016.

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My liver is not working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have serious side effects from past treatments that haven't improved.

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I have a history of serious gut issues that could affect medication absorption or increase my risk of stomach side effects.

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I haven't had chemotherapy or radiotherapy in the last 2 weeks or longer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment1 Intervention

Control - participants with normal hepatic function

Group II: Group 2Experimental Treatment1 Intervention

Group III: Group 1Experimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,678 Previous Clinical Trials

4,125,613 Total Patients Enrolled

12 Trials studying Tumors

2,128 Patients Enrolled for Tumors

Media Library

Onureg (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05209295 — Phase 1

Tumors Research Study Groups: Group 1, Group 2, Group 3

Tumors Clinical Trial 2023: Onureg Highlights & Side Effects. Trial Name: NCT05209295 — Phase 1

Onureg (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05209295 — Phase 1

~21 spots leftby Jun 2025

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