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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: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by Taiho Oncology.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Venetoclax area under the curve from time 0 to 24 hours (AUC0-24) with and without ASTX727 in Phase 1 and Phase 2, Part A.

Conditions Studied

Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 101 participants
Start Date 2021-02-09
Est. Completion 2026-12-31
Phase Phase 1
Taiho Oncology

52 total trials

What the registry record for NCT04657081 still lists

NCT04657081 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (13% lower).

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 names 20 study sites across 12 states, led by 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.

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 NCT04657081's enrollment target sits among peer trials

101 78th of 306 higher than 229 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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Related registry views

Source: ClinicalTrials.gov NCT04657081, the US trial registry maintained by the National Library of Medicine. NCT04657081 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.