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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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 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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,690 Previous Clinical Trials
4,097,508 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
~16 spots leftby Jun 2025
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