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NCT04953897 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 20
- Study locations
NCT04953897: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology.
NCT04953897 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 18 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04953897, 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
- 18 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1b, multicenter, open-label, 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 severe renal impairment and cancer participants with normal renal function as matched control participants. 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 per participant is approximately up to 8 weeks.
Primary Outcome
AUCtau from Day 1 to Day 5 for decitabine.
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
- START Madrid - CIOCC - HM Sanchinarro - Madrid
- Hospital Universitario 12 de Octubre - Madrid
- Hospital Clínico Universitario Virgen de la Arrixaca (Hematology Dept) - Murcia
- Hospital Clínico Universitario Virgen de la Arrixaca (Solid Tumor Dept) - Murcia
Texas
- MD Anderson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-12-15 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04953897 shows while recruiting
NCT04953897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% 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.
NCT04953897 names 20 study sites across 2 states, led by Other, Texas.
Frequently Asked Questions
What is clinical trial NCT04953897 about?
NCT04953897 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment". This is a Phase 1b, multicenter, open-label, 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 severe renal impairment and cancer...
What is the current status of trial NCT04953897?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-12-15. Estimated completion is 2026-12.
What conditions does trial NCT04953897 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT04953897?
The interventions under investigation include: ASTX727 (DRUG).
Who is sponsoring clinical trial NCT04953897?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04953897 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
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Where NCT04953897's enrollment target sits among peer trials
18 259th of 306 higher than 40 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.
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