A Study of SNDX-5613 in R/R Leukemias Including Those With an MLL/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 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 SNDX-5613.

Objectives

Phase 1: Oral SNDX-5613; sequential cohorts of escalating dose levels of SNDX-5613 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) inhibitor/inducers
or fluconazole.

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

Arm C: Participants receiving SNDX-5613 and cobicistat.

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

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

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 SNDX-5613:

- Cohort 2A: Participants with KMT2Ar acute lymphoblastic leukemia (ALL)/mixed phenotype
acute leukemia (MPAL)

- Cohort 2B: Participants with KMT2A AML

- Cohort 2C: Participants with NPM1m 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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.