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NCT04243785 · ClinicalTrials.gov registry record · Phase 1

A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Edgewood Oncology.

Recruiting
Registry status
Phase 1
Development phase
80
Enrollment target
3
Study locations

NCT04243785 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Edgewood Oncology. The registered enrollment target is 80 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (31% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT04243785, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Edgewood Oncology.

RECRUITING
Registry status
Phase 1
Development phase
80 participants
Enrollment target
3
Study locations

Study Summary

This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study will be done in three parts. Part 1a (Monotherapy Dose Escalation) of this study is designed to determine the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of orally administered BTX-A51 in up to 35 participants who are evaluable for toxicity. Once the MTD is determined, it is planned that an additional 15 participants will be enrolled in Part 1b (Monotherapy Cohort Expansion) of this study for additional experience with safety and efficacy, and to determine the recommended Phase 2 dose (RP2D) which may or may not be different from the MTD. After determination of MTD and RP2D from Part 1a, Part 1c (Azacitidine Combination Dose Escalation) will enroll up to 30 participants. Continued treatment will be available under this study protocol for up to eight 28-day cycles (Continued Treatment Phase) if the Investigator judges the benefit outweighs the risk. Once BTX-A51 treatment has completed, participants will be contacted by telephone every 3 months for up to 2 years after their last treatment for survival status and anticancer therapy (Overall Survival Follow-up).

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome

Interventions

  • DRUG Azacitidine
  • DRUG BTX-A51

Study Locations (3)

California

  • City of Hope National Medical Center - Duarte

New York

  • Memorial Sloan-Kettering Cancer Center - New York

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2020-01-06
Est. Completion 2027-03
Phase Phase 1

Sponsor

Edgewood Oncology

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04243785

The ClinicalTrials.gov registry entry for NCT04243785 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 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 (31% lower). The listed sponsor is Edgewood Oncology, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.

NCT04243785 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, New York, Texas.

Frequently Asked Questions

What is clinical trial NCT04243785 about?

NCT04243785 is a clinical study titled "A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study will be done i...

What is the current status of trial NCT04243785?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2020-01-06. Estimated completion is 2027-03.

What conditions does trial NCT04243785 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.

What interventions are being tested in trial NCT04243785?

The interventions under investigation include: Azacitidine (DRUG), BTX-A51 (DRUG).

Who is sponsoring clinical trial NCT04243785?

This trial is sponsored by Edgewood Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04243785 being conducted?

This trial has 3 study locations across California, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.