SNDX-5613 for Leukemia, Myeloid, Acute
Phase-Based Progress Estimates
Effectiveness
Safety
M D Anderson Cancer Center, Houston, TX
Leukemia, Myeloid, Acute+3 More
SNDX-5613 - DrugEligibility
Any Age
All Sexes
What conditions do you have?
Select
Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL). Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL
Eligible Conditions
- Leukemia, Myeloid, Acute
- Leukemia, Myelocytic, Acute
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year
Year 1
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).
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Venetoclax
1 of 3
SNDX-5613
1 of 3
ASTX727
1 of 3
Experimental Treatment
43 Total Participants · 3 Treatment Groups
Primary Treatment: SNDX-5613 · No Placebo Group · Phase 1 & 2
Venetoclax
Drug
Experimental Group · 1 Intervention: Venetoclax · Intervention Types: DrugSNDX-5613
Drug
Experimental Group · 1 Intervention: SNDX-5613 · Intervention Types: DrugASTX727
Drug
Experimental Group · 1 Intervention: ASTX727 · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1670
ASTX727
2018
Completed Phase 3
~200
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
Closest Location: M D Anderson Cancer Center · Houston, TX
2003First Recorded Clinical Trial
93 TrialsResearching Leukemia, Myeloid, Acute
465 CompletedClinical Trials
Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Industry Sponsor
92 Previous Clinical Trials
7,955 Total Patients Enrolled
15 Trials studying Leukemia, Myeloid, Acute
2,939 Patients Enrolled for Leukemia, Myeloid, Acute
Syndax Pharmaceuticals, Inc.UNKNOWN
3 Previous Clinical Trials
115 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,772 Previous Clinical Trials
1,795,169 Total Patients Enrolled
143 Trials studying Leukemia, Myeloid, Acute
10,837 Patients Enrolled for Leukemia, Myeloid, Acute
Ghayas Issa, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have relapsed/refractory AML or MPAL with a myeloid phenotype.
You have adequate renal function.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Cancer Related
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