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Tyrosine Kinase Inhibitor

Ensartinib for Cancer

Phase 2

Recruiting

Led By Meredith S Irwin

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment

Stem cell Infusions (with or without total body irradiation [TBI])

Must not have

Patients who have an uncontrolled infection

Anti-GVHD agents post-transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations.

Who is the study for?

This trial is for children and young adults up to 21 years old with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic changes (ALK or ROS1) and haven't responded to previous treatments. Participants need normal organ function, must be able to swallow capsules, and can't have had ensartinib before.

What is being tested?

The study tests how well the drug ensartinib works on patients with certain recurrent or refractory cancers. It includes various imaging studies like MRIs and bone scans to monitor the effects of the treatment which aims at blocking enzymes important for cancer cell growth.

What are the potential side effects?

While not explicitly listed in your information provided, drugs like ensartinib typically may cause side effects such as fatigue, nausea, liver issues (elevated liver enzymes), vision problems, muscle pain, weight gain due to fluid retention and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 21 years old.

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I have had a stem cell transplant, with or without full body radiation.

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I can swallow pills without any issues.

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My body surface area is at least 0.5 square meters.

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I have not undergone radiopharmaceutical therapy.

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My kidney function, measured by creatinine clearance or GFR, is normal or above.

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I have received external beam radiation therapy.

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My bilirubin levels are within the normal range for my age.

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I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation.

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I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections that are currently uncontrolled.

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I am taking medication to prevent graft-versus-host disease after a transplant.

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I am currently taking corticosteroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate

Secondary study objectives

Percentage of patients experiencing grade 3 or higher adverse events

Pharmacokinetic (PK) parameters

Progression free survival (PFS)

Other study objectives

Biomarkers as predictors of response to ensartinib

Changes in tumor genomic profile

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ensartinib)Experimental Treatment11 Interventions

Patients receive ensartinib PO QD on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Radionuclide Imaging

2004

Completed Phase 2

~50