Epigenetic Modifiers

SNDX-5613 for Acute Leukemia

MD Anderson Cancer Center, Houston, TX
SNDX-5613Phase 1RecruitingResearch Sponsored by Syndax Pharmaceuticals

Study Summary

This trial will study how a new cancer drug is absorbed, metabolized, and excreted in male patients with AML.

Eligible Conditions
  • Acute Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your liver and heart are working well enough for you to participate in the study.
You have already received the usual treatment for your condition.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount Excreted in Feces (Aef)
Amount Excreted in Urine (Aeu)
Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)
+3 more
Secondary outcome measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SNDX-5613Experimental Treatment1 Intervention
Participants will be administered a single dose of SNDX-5613 (containing ~100 microcuries [14C]-SNDX-5613) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled SNDX-5613. SNDX-5613 may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity.

Find a site

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
42 Previous Clinical Trials
2,537 Total Patients Enrolled
Nicole McNeer, MD, PhDStudy Director
Syndax Pharmaceuticals
1 Previous Clinical Trials
54 Total Patients Enrolled
Kate Madigan, M.D.Study Director
Syndax Pharmaceuticals
1 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

SNDX-5613 (Epigenetic Modifiers) Clinical Trial Eligibility Overview. Trial Name: NCT05406817 — Phase 1
Acute Leukemia Research Study Groups: SNDX-5613
Acute Leukemia Clinical Trial 2023: SNDX-5613 Highlights & Side Effects. Trial Name: NCT05406817 — Phase 1
SNDX-5613 (Epigenetic Modifiers) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05406817 — Phase 1

Frequently Asked Questions

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

Is SNDX-5613 a secure option for individuals?

"With limited data supporting both safety and efficacy, a score of 1 is attributed to the investigational drug SNDX-5613. This rating reflects its Phase 1 trial status."

Answered by AI

How many participants is the research team aiming to recruit?

"That is indeed accurate. According to the information presented on clinicaltrials.gov, this medical trial began recruiting participants on August 5th 2022 and was last updated October 3rd 2022. The study requires 8 individuals from a single location for enrolment."

Answered by AI

Are there any vacancies left for participants in this research protocol?

"Affirmative. According to clinicaltrials.gov, this research trial posted on August 5th 2022 is currently enrolling patients and seeking 8 participants across one site. The information was last modified October 3rd of the same year."

Answered by AI
~3 spots leftby May 2024