Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-12-23 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04953910
The ClinicalTrials.gov registry entry for NCT04953910 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (77% lower). The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.
-
A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)
RECRUITING · Phase 1
-
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
RECRUITING · Phase 1
-
FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML
RECRUITING · Phase 1
-
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.