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NCT04657081 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Taiho Oncology.
- Active
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT04657081 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Taiho Oncology. The registered enrollment target is 101 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT04657081, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Taiho Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Decitabine and Cedazuridine (ASTX727)
Study Locations (20)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Weill Cornell Medical College - New York
- University of Rochester - Rochester
- The Research Foundation of the State University of New York (SUNY) - Syracuse
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
- University of Massachusetts, Memorial Medical Center - Worcester
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- Stanford University - Palo Alto
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
- Boca Raton Clinical Research - Plantation
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
- UPMC Hillman Cancer Center - Pittsburgh
Connecticut
- Yale University - New Haven
Illinois
- The University of Chicago Medical Center - Chicago
Indiana
- Indiana University Simon Cancer Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04657081
The ClinicalTrials.gov registry entry for NCT04657081 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 101 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 (13% lower). The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.
NCT04657081 reports 20 study locations spanning 12 distinct geographic areas - top geographies include New York, Massachusetts, California.
Frequently Asked Questions
What is clinical trial NCT04657081 about?
NCT04657081 is a clinical study titled "Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)". The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML...
What is the current status of trial NCT04657081?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2021-02-09. Estimated completion is 2026-12-31.
What conditions does trial NCT04657081 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04657081?
The interventions under investigation include: Venetoclax (DRUG), Decitabine and Cedazuridine (ASTX727) (DRUG).
Who is sponsoring clinical trial NCT04657081?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04657081 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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