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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 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
~2790
Radionuclide Imaging
2004
Completed Phase 2
~50
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Bone Scan
2015
Completed Phase 2
~50
Ensartinib
2017
Completed Phase 2
~50
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biospecimen Collection
2004
Completed Phase 3
~2030
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,482 Total Patients Enrolled
Children's Oncology GroupNETWORK
460 Previous Clinical Trials
239,900 Total Patients Enrolled
Meredith S IrwinPrincipal InvestigatorChildren's Oncology Group

Media Library

Ensartinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03213652 — Phase 2
Solid Tumors Research Study Groups: Treatment (ensartinib)
Solid Tumors Clinical Trial 2023: Ensartinib Highlights & Side Effects. Trial Name: NCT03213652 — Phase 2
Ensartinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03213652 — Phase 2
~29 spots leftby Sep 2027