Study of Radiolabeled Revumenib in Adults With Acute Leukemia

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: Acute Leukemia
• Intervention / Treatment: Drug: Revumenib

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Refractory leukemia; Acute Leukemia; SNDX-5613; Relapsed leukemia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Acute Disease
• 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