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A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation


Active: Yes
Cancer Type: Leukemia NCT ID: NCT04065399
Trial Phases: Phase I
Phase II
Protocol IDs: SNDX-5613-0700 (primary)
NCI-2019-07963
Eligibility: 30 Days and older, Male and Female Study Type: Treatment
Study Sponsor: Syndax Pharmaceuticals
NCI Full Details: http://clinicaltrials.gov/show/NCT04065399

Summary

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase
2 dose (RP2D) of SNDX-5613 in patients with acute leukemia.

In Phase 2, patients will be enrolled in 3 indication-specific expansion cohorts to determine
the efficacy, short- and long-term safety, and tolerability of SNDX-5613.

Objectives

Phase 1: Oral SNDX-5613; sequential cohorts of escalating dose levels of SNDX-5613 to
identify the MTD and RP2D. Patients will be enrolled in one of six dose-escalation arms:

Arm A: Patients not receiving any strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers or
fluconazole.

Arm B: Patients receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong
CYP3A4 inhibitors) for antifungal prophylaxis.

Arm C: Patients receiving SNDX-5613 and cobicistat.

Arm D: Patients receiving fluconazole (moderate CYP3A4 inhibitor) for antifungal prophylaxis.

Arm E: Patients not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers.

Arm F: Patients receiving isavuconazole (moderate CYP3A4 inhibitor) for antifungal
prophylaxis.

In Phase 2, patients will be enrolled in 3 indication-specific expansion cohorts to determine
the efficacy, short- and long-term safety, and tolerability of SNDX-5613:

- Cohort 2A: Patients with MLLr acute lymphoblastic leukemia (ALL)/mixed phenotype acute
leukemia (MPAL).

- Cohort 2B: Patients with MLLr AML.

- Cohort 2C: Patients with NPM1c AML.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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