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NCT04256317 · ClinicalTrials.gov registry record · Phase 2
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT04256317: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Taiho Oncology.
NCT04256317 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Taiho Oncology. The registered enrollment target is 316 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (175% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04256317, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Taiho Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML. The duration of this multi-phase study is approximately 8 years.
Primary Outcome
Ratio of azacitidine total cycle AUC0-24 exposures after oral ASTX030 over SC azacitidine.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG ASTX030 (cedazuridine + azacitidine)
- DRUG Cedazuridine
Study Locations (20)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- New York University Langone Hospital - Long Island - Mineola
- Perlmutter Cancer Center - 34th Street - New York
- Icahn School of Medicine at Mount Sinai - New York
- Weill Cornell Medical Center - New York
- University of Rochester - Wilmot Cancer Center - Rochester
- Montefiore Medical Center - The Bronx
California
- Keck School of Medicine of USC - Los Angeles
- UC Irvine Health - Chao Family Comprehensive Cancer Center - Orange
Oregon
- Oregon Health and Science University - Portland
- Oregon Oncology Specialists - Salem
Connecticut
- Yale University - New Haven
Florida
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
Georgia
- University of Emory - Winship Cancer Institute - Atlanta
Massachusetts
- Dana-Farber Cancer Institute - Boston
New Jersey
- John Theurer Cancer Center / Hackensack University - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 2 |
What NCT04256317 shows while recruiting
NCT04256317 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (175% higher).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Azacitidine is the first listed.
NCT04256317 names 20 study sites across 12 states, led by New York, California, Oregon.
Frequently Asked Questions
What is clinical trial NCT04256317 about?
NCT04256317 is a clinical study titled "A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)". Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (on...
What is the current status of trial NCT04256317?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2020-05-21. Estimated completion is 2028-11-01.
What conditions does trial NCT04256317 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome/Neoplasm.
What interventions are being tested in trial NCT04256317?
The interventions under investigation include: Azacitidine (DRUG), ASTX030 (cedazuridine + azacitidine) (DRUG), Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT04256317?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04256317 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04256317's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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