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Tyrosine Kinase Inhibitor

Savolitinib for Brain Tumors

Phase 1

Recruiting

Led By Ralph Salloum

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 able to swallow whole tablets

Patients must meet specific hematologic, hepatic, renal, and cardiac function criteria

Must not have

Patients with any clinically significant unrelated systemic illness or significant organ dysfunction

Patients receiving certain concurrent therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of volitinib for treating patients with primary CNS tumors that have come back or does not respond to treatment.

Who is the study for?

This trial is for young patients aged 5 to 21 with recurrent or stubborn primary CNS tumors, including medulloblastoma and gliomas. They must have tried standard treatments without success, be able to swallow tablets, and have stable neurological conditions. Pregnant women, nursing mothers, those with serious infections or other significant illnesses are excluded.

What is being tested?

The trial tests the safety and optimal dosage of volitinib on children and young adults with specific brain tumors that haven't responded to previous treatments. It involves biospecimen collection and imaging techniques like MRI alongside the administration of volitinib.

What are the potential side effects?

Potential side effects include issues related to blocking enzymes needed for cell growth which may affect various body functions but specifics aren't provided here. Patients will be monitored for any adverse reactions during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow whole tablets.

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My blood, liver, kidney, and heart are functioning within normal ranges.

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I meet the requirements for a stem cell transplant.

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My physical ability is rated by a doctor's scale.

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My kidney function tests are within the normal range for my age and gender.

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My brain tumor has come back, is not responding, or is getting worse.

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I am between 5 and 21 years old.

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My body size meets the specific requirements for the trial's dose levels.

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My heart is functioning within the required range.

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 major illnesses or organ problems unrelated to my cancer.

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I am currently on other treatments.

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I have a heart condition.

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My high blood pressure is not under control.

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I currently have a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Maximum tolerated dose of volitinib

Secondary study objectives

Molecular analyses of tumors

Objective responses (complete response + partial response)

Pharmacokinetic Parameters

+1 more

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 (volitinib)Experimental Treatment4 Interventions

Patients receive volitinib PO QD. Treatment repeats every 28 days for up to 39 courses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, X-ray imaging, and MRI scans throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Biospecimen Collection

2004

Completed Phase 3

~2030