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Epigenetic Modifiers

Radiolabeled SNDX-5613 for Acute Leukemia

Phase 1

Recruiting

Research Sponsored by Syndax Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2

Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

Study Summary

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

Who is the study for?

Adults over 18 with acute leukemia, either relapsed or refractory, including those who are MRD-positive. Participants must have an ECOG score of 0-2 and adequate liver/cardiac function. Men must agree to use barrier contraception for a specified period post-treatment. Exclusions include high WBC count at enrollment, active viral infections like HIV or hepatitis B/C, recent participation in other drug trials, and certain medical conditions.Check my eligibility

What is being tested?

The trial is testing SNDX-5613's absorption, metabolism, and excretion in adults with acute leukemia. It's an open-label study which means everyone knows they're getting the test drug ([14C])-SNDX-5613 without any comparison to a placebo.See study design

What are the potential side effects?

While specific side effects of SNDX-5613 aren't listed here, common side effects for similar leukemia treatments can include nausea, fatigue, risk of infection due to low blood cell counts, bleeding or bruising easily from low platelet counts.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My acute leukemia has returned or didn't respond to treatment, and tests show minimal residual disease.

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I have received the standard treatment for my 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

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)

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor

48 Previous Clinical Trials

2,766 Total Patients Enrolled

Nicole McNeer, MD, PhDStudy DirectorSyndax Pharmaceuticals

1 Previous Clinical Trials

30 Total Patients Enrolled

Kate Madigan, M.D.Study DirectorSyndax Pharmaceuticals

1 Previous Clinical Trials

30 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

Recent research and studies

clinicaltrials.govStudy

Study of Radiolabeled SNDX-5613 in Adults With Acute Leukemia

2022. "Study of Radiolabeled SNDX-5613 in Adults With Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05406817.