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DNA Methyltransferase Inhibitor

SNDX-5613 + ASTX727 + Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Ghayas Issa, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and at least 3 months after the last treatment
Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 7 days prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors/inducers
Must not have
Patients with Grade > 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity
Patients with a concurrent active malignancy under treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

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

Who is the study for?
This trial is for individuals aged 12 and older, weighing at least 40kg, with relapsed/refractory acute myeloid leukemia (AML) or mixed phenotype acute leukemia with a myeloid phenotype. Participants must have an ECOG performance status of ≤2, be on certain antifungal medications, and not be taking other strong CYP3A4 inhibitors/inducers. They should agree to contraception use during the study and for three months after. Exclusions include active malignancy under treatment, severe gastrointestinal/metabolic conditions affecting drug absorption, recent significant cardiovascular events, uncontrolled medical conditions or infections.
What is being tested?
The trial is testing the highest tolerable dose of SNDX-5613 in combination with ASTX727 (decitabine/cedazuridine) and venetoclax in patients with AML or MPAL. The goal is to determine if this oral drug combination can control these types of leukemia effectively.
What are the potential side effects?
Potential side effects may include digestive issues due to oral medication intake; blood disorders from bone marrow suppression; increased risk of infection; liver function abnormalities; heart problems such as arrhythmias or reduced heart function; fatigue from anemia or other causes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male who is sterile or will use contraception during and 3 months after the study.
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I am taking certain antifungal medications and no other strong medications that affect drug metabolism.
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My leukemia has returned or is not responding to treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I am 12 years or older and weigh at least 40kg.
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My liver is functioning well, based on my bilirubin and AST/ALT levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe acute or chronic graft-versus-host disease.
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I am currently being treated for another cancer.
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I haven't had a heart attack, severe heart issues, or a stroke in the last 6 months.
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I do not have severe stomach or metabolic issues affecting medication absorption.
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I have an ongoing infection that isn't under control.
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I am not pregnant or breastfeeding.
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I do not have any uncontrolled medical, mental health issues, or lab abnormalities that could make the study unsafe for me.
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I have an active hepatitis B, hepatitis C, or HIV infection.
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My leukemia is affecting my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
ASTX727
2018
Completed Phase 3
~270
Venetoclax
FDA approved

Find a Location

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
174 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,502 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,482 Total Patients Enrolled
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,651 Total Patients Enrolled
Ghayas Issa, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
63 Total Patients Enrolled

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
~20 spots leftby Dec 2026
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