SNDX-5613 for Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MD Anderson Cancer Center, Houston, TX
Leukemia+3 More
SNDX-5613 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This is an open-label study to study the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-SNDX-5613 in adult males with acute myeloid leukemia (AML).

Eligible Conditions

  • Leukemia
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Study Objectives

6 Primary · 1 Secondary · Reporting Duration: up to approximately 1 year

Up to Day 11
Amount Excreted in Feces (Aef)
Amount Excreted in Urine (Aeu)
Percentage of Dose Excreted in Feces (fef)
Percentage of Dose Excreted in Urine (feu)
Up to Day 21
Area Under The Curve from Time 0 to The Last Measurable Concentration (AUC0-t)
Maximum Observed Concentration (Cmax)
Year 1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Trial Safety

Trial Design

1 Treatment Group

SNDX-5613
1 of 1
Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: SNDX-5613 · No Placebo Group · Phase 1

SNDX-5613
Drug
Experimental Group · 1 Intervention: SNDX-5613 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 1 year
Closest Location: MD Anderson Cancer Center · Houston, TX
Photo of MD Anderson Cancer Center  1Photo of MD Anderson Cancer Center  2Photo of MD Anderson Cancer Center  3
2004First Recorded Clinical Trial
153 TrialsResearching Leukemia
520 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have active AML.\n
You have a performance status score of 0 to 2.
You have adequate liver and cardiac function.
You are male and you agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.