Epigenetic Modifiers
SNDX-5613 for Acute Leukemia
MD Anderson Cancer Center, Houston, TX
SNDX-5613Phase 1RecruitingResearch Sponsored by Syndax PharmaceuticalsEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver and cardiac function
Previously received standard of care therapy
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to approximately 1 year
Awards & highlights
No Placebo-Only Group
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 belowSelect...
Your liver and heart are working well enough for you to participate in the study.
Select...
You have already received the usual treatment for your condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
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 moreSecondary 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.
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Who is running the clinical trial?
Syndax PharmaceuticalsLead Sponsor
42 Previous Clinical Trials
2,537 Total Patients Enrolled
Nicole McNeer, MD, PhDStudy Director
Syndax Pharmaceuticals1 Previous Clinical Trials
54 Total Patients Enrolled
Kate Madigan, M.D.Study Director
Syndax Pharmaceuticals1 Previous Clinical Trials
54 Total Patients Enrolled
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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