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ACTIVE NOT RECRUITING Phase 1

Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

NCT04657081 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Taiho Oncology

46 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04657081 reports 20 study locations spanning 12 distinct geographic areas — top geographies include New York, Massachusetts, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04657081?

The interventions under investigation include: Venetoclax (DRUG), Decitabine and Cedazuridine (ASTX727) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04657081?

This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial