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Cytidine Deaminase Inhibitor

Entrectinib + ASTX727 for Acute Myeloid Leukemia

Q: 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.

Q: 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.

Q: 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.

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 weeks3 visits

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

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

0 / 6Eligibility criteria met

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

1,540 Previous Clinical Trials

567,887 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

Recent research and studies

clinicaltrials.govStudy

Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia

Ronan Swords, M.D. 2022. "Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05396859.