Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04065399
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2019-08-16
Brief Title:
A Study of Revumenib in RR Leukemias Including Those With an MLLKMT2A Gene Rearrangement or NPM1 Mutation
Sponsor:
Syndax Pharmaceuticals
Organization:
Syndax Pharmaceuticals
Study Overview
Official Title:
A Phase 12 Open-label Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With RelapsedRefractory Leukemias Including Those Harboring an MLLKMT2A Gene Rearrangement or Nucleophosmin 1 NPM1 Mutation
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:
AUGMENT-101
Brief Summary:
Phase 1 dose escalation will determine the maximum tolerated dose MTD and recommended Phase 2 dose RP2D of revumenib in participants with acute leukemia
In Phase 2 participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy short- and long-term safety and tolerability of revumenib
In Phase 2 participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy short- and long-term safety and tolerability of revumenib
Detailed Description:
Phase 1 Oral revumenib sequential cohorts of escalating dose levels of revumenib to identify the MTD and RP2D Participants will be enrolled in one of six dose-escalation arms
Arm A Participants not receiving any strong cytochrome P450 3A4 CYP3A4 inhibitorinducers or fluconazole
Arm B Participants receiving itraconazole ketoconazole posaconazole or voriconazole strong CYP3A4 inhibitors for antifungal prophylaxis
Arm C Participants receiving revumenib and cobicistat
Arm D Participants receiving fluconazole moderate CYP3A4 inhibitor for antifungal prophylaxis
Arm E Participants not receiving any weak moderate or strong CYP3A4 inhibitorsinducers
Arm F Participants receiving isavuconazole moderate CYP3A4 inhibitor for antifungal prophylaxis
In Phase 2 participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy short- and long-term safety and tolerability of revumenib
Cohort 2A Participants with KMT2Ar acute lymphoblastic leukemia ALLmixed phenotype acute leukemia MPAL
Cohort 2B Participants with KMT2A AML
Cohort 2C Participants with NPM1m AML
Arm A Participants not receiving any strong cytochrome P450 3A4 CYP3A4 inhibitorinducers or fluconazole
Arm B Participants receiving itraconazole ketoconazole posaconazole or voriconazole strong CYP3A4 inhibitors for antifungal prophylaxis
Arm C Participants receiving revumenib and cobicistat
Arm D Participants receiving fluconazole moderate CYP3A4 inhibitor for antifungal prophylaxis
Arm E Participants not receiving any weak moderate or strong CYP3A4 inhibitorsinducers
Arm F Participants receiving isavuconazole moderate CYP3A4 inhibitor for antifungal prophylaxis
In Phase 2 participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy short- and long-term safety and tolerability of revumenib
Cohort 2A Participants with KMT2Ar acute lymphoblastic leukemia ALLmixed phenotype acute leukemia MPAL
Cohort 2B Participants with KMT2A AML
Cohort 2C Participants with NPM1m AML
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004104-34 | EUDRACT_NUMBER | None | None |