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 CenterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new combination of drugs for leukemia.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2170
ASTX727
2018
Completed Phase 3
~200
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Logistics
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 CenterMedia Library
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