Study of Radiolabeled Revumenib in Adults With Acute Leukemia

NCT ID: NCT05406817

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2024-11-18

Brief Summary

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

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.

Conditions

Acute Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Revumenib

Intervention Type: DRUG

Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.

Interventions

Revumenib

Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.

Intervention Type: DRUG

Other Intervention Names

SNDX-5613

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syndax Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole McNeer, MD, PhD

Role: STUDY_DIRECTOR

Syndax Pharmaceuticals

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

SNDX-5613-0705

Identifier Type: -

Identifier Source: org_study_id