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NCT04953910 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology.

Recruiting
Registry status
Phase 1
Development phase
27
Enrollment target
20
Study locations

NCT04953910: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology.

NCT04953910 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Taiho Oncology. The registered enrollment target is 27 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04953910, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Taiho Oncology.

RECRUITING
Registry status
Phase 1
Development phase
27 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with moderate and severe hepatic impairment and cancer participants with normal hepatic function as control participants. Participants with severe hepatic impairment will be enrolled only after the safety evaluation of at least 6 participants with moderate hepatic impairment has been determined and supports the enrollment of participants with severe hepatic impairment. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration is per participant approximately up to 8 weeks.

Primary Outcome

AUCtau from Day 1 to Day 5 for decitabine.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndromes

Interventions

  • DRUG ASTX727

Study Locations (20)

Other

  • Erebuni Medical Center - Yerevan
  • Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders) - Yerevan
  • Hematology Center After Prof. R. Yeolyan (Clinic of Adults Oncology) - Yerevan
  • National Center of Oncology Named After V.A. Fanarjyan - Yerevan
  • Complex Oncology Center - Plovdiv - Base II - Plovdiv
  • BIO1 - Vilnius
  • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. - Wroclaw
  • Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu - Bucharest
  • Institutul Oncologic Prof. Dr. Ion Chiricuta - Cluj-Napoca
  • Summit Clinical Research s.r.o - Bratislava
  • START Barcelona - Hospital HM Nou Delfos - Barcelona
  • Hospital Universitari Dexeus - Grupo Quirónsalud - Barcelona
  • START Rioja - Hospital de San Pedro - La Rioja
  • Hospital Universitari Arnau de Vilanova - Lleida
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz - Madrid
  • Hospital Universitario La Paz - Madrid
  • START Madrid - CIOCC - HM Sanchinarro - Madrid
  • Hospital Universitario 12 de Octubre - Madrid
  • Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept) - Murcia

Texas

  • MD Anderson - Houston

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2022-12-23
Est. Completion 2026-12
Phase Phase 1
Taiho Oncology

52 total trials

What NCT04953910 shows while recruiting

NCT04953910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (77% lower).

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which ASTX727 is the first listed.

NCT04953910 names 20 study sites across 2 states, led by Other, Texas.

Frequently Asked Questions

What is clinical trial NCT04953910 about?

NCT04953910 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment". This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with moderate and sev...

What is the current status of trial NCT04953910?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-12-23. Estimated completion is 2026-12.

What conditions does trial NCT04953910 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.

What interventions are being tested in trial NCT04953910?

The interventions under investigation include: ASTX727 (DRUG).

Who is sponsoring clinical trial NCT04953910?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04953910 being conducted?

This trial has 20 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04953910's enrollment target sits among peer trials

27 215th of 306 higher than 89 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04953910

Source: ClinicalTrials.gov NCT04953910, the US trial registry maintained by the National Library of Medicine. NCT04953910 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.