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Cytidine Deaminase Inhibitor

Entrectinib + ASTX727 for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Ronan T Swords, M.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function as defined by calculated creatinine clearance (according to the Cockcroft-Gault equation) > 40 mL/min OR serum creatinine < 1.5 × ULN
Documented TP53 mutation as seen on standard diagnostics in AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug up to 2 weeks after last dose of study drug, start of new cancer therapy, or transplant (whichever is first), assessed up to 6 months
Awards & highlights

Study Summary

This trial is testing the safety of a combination of drugs for patients with leukemia who have a specific genetic mutation. The combination of drugs may kill more cancer cells than either drug alone.

Who is the study for?
Adults with relapsed/refractory AML and a TP53 mutation can join this trial. They must understand the study, be able to take oral meds, have decent organ function, and use contraception. Excluded are those with certain leukemia types, active infections like HIV or hepatitis B/C, uncontrolled diseases, recent investigational drugs usage or conditions affecting drug absorption.Check my eligibility
What is being tested?
The trial is testing entrectinib combined with ASTX727 (cedazuridine plus decitabine) for safety and effectiveness in AML patients. Entrectinib blocks cancer cell growth signals; cedazuridine increases decitabine's availability which helps produce normal blood cells and kills abnormal ones.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation of organs, infusion-related symptoms, fatigue from treatment burden on the body, digestive issues due to medication impact on gut health, possible blood disorders from bone marrow activity changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range.
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My AML has a confirmed TP53 mutation.
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My AML has returned or didn't respond to treatment, with at least 20% cancer cells in my blood or bone marrow.
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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 18 years old or older.
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I can take medicine by mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug up to 2 weeks after last dose of study drug, start of new cancer therapy, or transplant (whichever is first), assessed up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to 2 weeks after last dose of study drug, start of new cancer therapy, or transplant (whichever is first), assessed up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs)
Secondary outcome measures
Clinical benefit rate (CBR)
Composite complete remission (CCR) rate
Duration of response (DOR)
+5 more
Other outcome measures
Pyruvate Kinase
Genomic analysis
NTRK gene expression
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ASTX727, entrectinib)Experimental Treatment3 Interventions
Patients receive entrectinib PO QD on days 1-28 and ASTX727 PO QD on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entrectinib
FDA approved

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,714 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,743 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,572 Total Patients Enrolled

Media Library

Acute Myelogenous Leukemia Research Study Groups: Treatment (ASTX727, entrectinib)

Frequently Asked Questions

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

Is this research endeavor currently open to new participants?

"Yes, per the information available on clinicaltrials.gov this experiment is actively looking for participants. Its original posting was October 28th 2022 and its most recent edit happened November 7th 2022."

Answered by AI

Has Entrectinib obtained regulatory approval from the FDA?

"Since only limited information is available on the safety and efficacy of Entrectinib, our team's evaluation places it at a score of 1."

Answered by AI

What is the cap on participants for this research endeavor?

"Yes, the clinicaltrials.gov portal has information that indicates this medical trial is still recruiting. It was initially posted on October 28th 2022 and last updated on November 7th 2022 - with a total of 12 patients being sought at 1 site."

Answered by AI
~4 spots leftby Dec 2024