DNA Methyltransferase Inhibitor

SNDX-5613 for Acute Myeloid Leukemia

M D Anderson Cancer Center, Houston, TX
SNDX-5613 +2 morePhase 1 & 2RecruitingLed by Ghayas Issa, MDResearch Sponsored by M.D. Anderson Cancer Center

Study Summary

This trial is testing a new combination of drugs for leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 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
To establish the recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML).

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: VenetoclaxExperimental Treatment1 Intervention
Tablets by mouth on Days 1-14 of each cycle.
Group II: SNDX-5613Experimental Treatment1 Intervention
Capsules by mouth 2 times every day (about 12 hours apart).
Group III: ASTX727Experimental Treatment1 Intervention
Tablets by mouth on Days 1-5 of each cycle.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 3

Find a site


Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Syndax Pharmaceuticals, Inc.UNKNOWN
4 Previous Clinical Trials
132 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,885 Previous Clinical Trials
1,781,156 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
93 Previous Clinical Trials
7,860 Total Patients Enrolled
Syndax PharmaceuticalsIndustry Sponsor
42 Previous Clinical Trials
2,502 Total Patients Enrolled
Ghayas Issa, MDPrincipal Investigator
M.D. Anderson Cancer Center

Media Library

ASTX727 (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05360160 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: SNDX-5613, Venetoclax, ASTX727
Acute Myeloid Leukemia Clinical Trial 2023: ASTX727 Highlights & Side Effects. Trial Name: NCT05360160 — Phase 1 & 2
ASTX727 (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05360160 — Phase 1 & 2

Frequently Asked Questions

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

Are people still being recruited for this experiment?

"From what is stated on clinicaltrials.gov, this trial is still looking for participants. The listing was first put up on October 14th 2022 and has had no changes since then."

Answered by AI

How many people are able to enroll in this trial?

"The trial is recruiting for 43 patients across 1 locations."

Answered by AI
~24 spots leftby Dec 2024