Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05406817
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2022-06-01
Brief Title:
Study of Radiolabeled Revumenib in Adults With Acute Leukemia
Sponsor:
Syndax Pharmaceuticals
Organization:
Syndax Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Open-label Study to Assess the Mass Balance Pharmacokinetics and Metabolism of Orally Administered 14C-SNDX-5613 in Patients With RelapsedRefractory Acute Leukemia
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05918913
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None