Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT05406817
Phase
PHASE1
Status
Completed

Conditions

  • Acute Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.

Study Details

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

Key Dates

Start date
Aug 5, 2022
Status verified
Jan 2025
Primary completion
Nov 18, 2024
Completion
Nov 18, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of Dose Excreted in Urine (feu) [ Time Frame: Up to Day 11 ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

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