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Liver study for cancer drug stopped early – only 2 people joined

NCT ID NCT05209295

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how moderate or severe liver problems change the amount of the cancer drug oral azacitidine in the blood. It was designed for adults with certain blood cancers. The study was stopped early after only 2 people enrolled, so the results are very limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

2 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia blast phase chronic myelogenous leukemia, BCR-ABL1 positive CD4+/CD56+ hematodermic neoplasm chronic myelomonocytic leukemia Hepatic Insufficiency leukemia, myeloid, accelerated-phase liver failure myelodysplastic syndrome myelodysplastic/myeloproliferative neoplasm myeloproliferative neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic insufficiency Neoplasms

Contacts and locations

Locations

  • Local Institution

    Cleveland, Ohio, 44106, United States

  • Local Institution - 0010

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Local Institution - 0011

    Pilar, Buenos Aires, 1629, Argentina

  • Local Institution - 0012

    Buenos Aires, 1426, Argentina

  • Local Institution - 0014

    Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

  • Local Institution - 0015

    Pamplona, Navarre, 31008, Spain

  • Local Institution - 0017

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Local Institution - 0018

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0069

    Detroit, Michigan, 48202, United States

  • Local Institution - 0074

    Hamburg, 20246, Germany

  • Local Institution - 0075

    Halle, Saxony-Anhalt, 06120, Germany

  • Local Institution - 0076

    Augsburg, Bavaria, 86156, Germany

  • Local Institution - 0078

    Salamanca, 37007, Spain

  • Local Institution - 0083

    Iowa City, Iowa, 52242, United States

  • Local Institution - 0084

    Bogota, Cundinamarca, 111151, Colombia

  • Local Institution - 0085

    Bogotá, Bogota D.C., 110131, Colombia

  • Local Institution - 0086

    Piedecuesta, Santander Department, 681017, Colombia

  • Local Institution - 9003

    Charlottesville, Virginia, 22903, United States

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