Study of Radiolabeled Revumenib in Adults With Acute Leukemia

January 8, 2025 updated by: Syndax Pharmaceuticals

A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia

This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-revumenib in participants with acute leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Males and females (of non-childbearing potential) aged ≥18 years
  • Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease.
  • Previously received standard of care therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Adequate liver and cardiac function
  • Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose

Key Exclusion Criteria:

  • Active diagnosis of acute promyelocytic leukemia
  • White blood cell (WBC) count >25,000/microliters at time of enrollment.
  • Detectable human immunodeficiency virus viral load within the previous 6 months
  • Hepatitis B or Hepatitis C
  • Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)
  • History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate
  • Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers
  • Any commercially available or investigational antileukemic therapy other than revumenib except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction
  • Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib
  • Any concurrent systemic treatment to prevent GVHD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revumenib

Participants will be administered a single dose of revumenib (containing ~100 microcuries [14C]-revumenib) in the AME part of the study.

Each dose administered after the first dose in the AME part of the study will be nonradiolabeled revumenib. revumenib may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity.
Drug: Revumenib
Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.
Other Names:
  • SNDX-5613

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Dose Excreted in Urine (feu)
Time Frame: Up to Day 11
Up to Day 11
Percentage of Dose Excreted in Feces (fef)
Time Frame: Up to Day 11
Up to Day 11
Amount Excreted in Urine (Aeu)
Time Frame: Up to Day 11
Up to Day 11
Amount Excreted in Feces (Aef)
Time Frame: Up to Day 11
Up to Day 11
Maximum Observed Concentration (Cmax)
Time Frame: Up to Day 21
Up to Day 21
Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)
Time Frame: Up to Day 21
Up to Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: up to approximately 1 year
up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syndax Pharmaceuticals

Investigators

  • Study Director: Nicole McNeer, MD, PhD, Syndax Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2022

Primary Completion (Actual)

November 18, 2024

Study Completion (Actual)

November 18, 2024

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNDX-5613-0705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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