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Epigenetic Modifiers

SNDX-5613 for Acute Leukemia (AUGMENT-101 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Syndax Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort 2C: Documented R/R AML with NPM1c.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

AUGMENT-101 Trial Summary

This trial is to test a new cancer drug to see what dose is best and if it is effective and safe.

Who is the study for?

This trial is for individuals with relapsed/refractory acute leukemias, specifically those with MLL rearrangement or NPM1 mutation. Participants must have a white blood cell count below 25,000/microliter and resolved prior treatment toxicities to ≤Grade 1 (except neuropathy or alopecia). They should not be on certain antifungal drugs unless specified in the study arms, have no active central nervous system disease, HIV viral load, hepatitis B/C, significant cardiac issues within the last six months, severe gastrointestinal conditions affecting drug absorption or serious graft-versus-host disease.Check my eligibility

What is being tested?

The trial tests SNDX-5613 alone or combined with cobicistat to determine its maximum tolerated dose and efficacy in treating specific types of leukemia. Phase 1 focuses on dosage while Phase 2 evaluates effectiveness and safety across different patient groups defined by their genetic mutations related to leukemia.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with leukemia treatments may include fatigue, nausea/vomiting, diarrhea/constipation, risk of infection due to low blood counts (neutropenia), bleeding/bruising from low platelet counts (thrombocytopenia), anemia causing tiredness and shortness of breath.

AUGMENT-101 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AML has relapsed or is resistant, and tests show NPM1c mutation.

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I am taking strong antifungal medication like itraconazole.

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I am not taking any medication that strongly affects liver enzymes.

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I have active acute leukemia with specific genetic changes.

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My leukemia has a specific genetic change known as MLLr.

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My AML cancer has a specific genetic change known as MLLr.

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It's been over 14 days or 5 half-lives since my last leukemia treatment.

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I am not taking strong CYP3A4 inhibitors/inducers or fluconazole.

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I am mostly active and can care for myself.

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I am currently taking fluconazole.

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I am taking isavuconazole for fungal infection prevention.

AUGMENT-101 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC0-t (Phase 1)

CR+CRh rate (Phase 2)

Cmax (Phase 1)

+4 more

Secondary outcome measures

AUC0-t (Phase 2)

CRc rate (Phase 2)

Cmax (Phase 2)

+7 more

AUGMENT-101 Trial Design

1Treatment groups

Experimental Treatment

Group I: SNDX-5613Experimental Treatment2 Interventions

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 1 of 6 dose-escalation arms: Arm A: Participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis Arm C: Participants receiving SNDX-5613 and cobicistat Arm D: Participants receiving fluconazole for antifungal prophylaxis Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers Arm F: Participants receiving isavuconazole for antifungal prophylaxis Phase 2: Oral SNDX-5613; Following the determination of the RP2D in Phase 1, 3 indication-specific expansion cohorts will be enrolled as follows: Cohort 2A: Participants with KMT2Ar ALL/MPAL Cohort 2B: Participants with KMT2Ar AML Cohort 2C: Participants with NPM1m AML

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cobicistat

2012

Completed Phase 1

~140

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor

48 Previous Clinical Trials

2,403 Total Patients Enrolled

Angie Smith, M.D.Study DirectorSyndax Pharmaceuticals

Galit Rosen, M.D.Study DirectorSyndax Pharmaceuticals, Inc.

Media Library

SNDX-5613 (Epigenetic Modifiers) Clinical Trial Eligibility Overview. Trial Name: NCT04065399 — Phase 1 & 2

Acute Leukemia Research Study Groups: SNDX-5613

Acute Leukemia Clinical Trial 2023: SNDX-5613 Highlights & Side Effects. Trial Name: NCT04065399 — Phase 1 & 2

SNDX-5613 (Epigenetic Modifiers) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04065399 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are we hoping to learn from this experiment?

"The primary purpose of this one year long clinical trial is to evaluate the frequency and severity of adverse events. Additionally, the study will also focus on secondary objectives such as duration of response, apparent volume of distribution, and best overall remission rate."

Answered by AI

Is this clinical trial widely available in Canada?

"Patients are able to enroll at Memorial Sloan Kettering Cancer Center in New york, The Hospital for Sick Children in Toronto, and Stanford Cancer Institute in Palo Alto among 16 other hospitals."

Answered by AI

What is the maximum number of patients that can join this trial?

"Yes, as of today, this clinical trial is recruiting patients. This experiment was originally posted on November 5th, 2019 and the most recent update was on July 28th, 2022. There are 440 total participants being recruited from 16 different locations."

Answered by AI

Are there opportunities for new patients to join this experiment?

"The trial, which was posted on November 5th 2019 and updated most recently on July 28th 2022, is looking for participants. This information comes from the clinicaltrials.gov website."

Answered by AI

Could you please provide more context on SNDX-5613 research?

"SNDX-5613 was first studied 18 years ago at University of Zurich. Since then, there have been 90 completed trials with 9 more currently underway. The majority of these ongoing studies are based in New york City."

Answered by AI

Recent research and studies

Current Opinion in HematologyJournal

Next Generation Epigenetic Modulators to Target Myeloid Neoplasms

Sasca, Daniel, Borhane Guezguez, and Michael W.M. Kühn. 2021. “Next Generation Epigenetic Modulators to Target Myeloid Neoplasms”. Current Opinion in Hematology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/moh.0000000000000673.

Molecular Cancer ResearchJournal

EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma

Jiménez, Jennifer A., April A. Apfelbaum, Allegra G. Hawkins, Laurie K. Svoboda, Abhijay Kumar, Ramon Ocadiz Ruiz, Alessandra X. Garcia, et al.. 2021. “EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma”. Molecular Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1541-7786.mcr-20-0679.

clinicaltrials.govStudy

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

2019. "A Study of SNDX-5613 in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065399.