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This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-revumenib in participants with acute leukemia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revumenib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revumenib | Drug | Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter. |
|
| Measure | Description | 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 | |
| Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t) | Up to Day 21 | |
| Maximum Observed Concentration (Cmax) | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | up to approximately 1 year |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole McNeer, MD, PhD | Syndax Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000728983 | revumenib |
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