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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with a specific blood cancer as per WHO 2016.
Select...
My liver is not working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point
AUC0-∞: Estimation of AUC calculated from time zero to infinity
Cmax: Observed maximum concentration
Secondary outcome measures
Incidence of adverse events
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Hematologic Tests
+12 moreTrial 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
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,130,032 Total Patients Enrolled
12 Trials studying Tumors
2,128 Patients Enrolled for Tumors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a specific blood cancer as per WHO 2016.I still have serious side effects from past treatments that haven't improved.I have a history of serious gut issues that could affect medication absorption or increase my risk of stomach side effects.My liver is not working well.I haven't had chemotherapy or radiotherapy in the last 2 weeks or longer.My kidney function has been stable without needing dialysis for at least 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to become involved in this clinical exploration?
"The clinical trial, which was initially created on the 11th of November 2022 and last edited on 13th January 2022, is not presently recruiting participants. However, there are 2420 other studies in progress that require volunteers."
Answered by AI
What detrimental effects may be associated with Vidaza treatment?
"Due to the limited data on Vidaza's safety and efficacy, it received an assessment score of 1."
Answered by AI
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