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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of volitinib
Recommend phase II dose
Secondary outcome measures
Molecular analyses of tumors
Objective responses (complete response + partial response)
Pharmacokinetic Parameters
+1 more

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
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Savolitinib
2019
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,439 Total Patients Enrolled
Ralph SalloumPrincipal InvestigatorPediatric Brain Tumor Consortium
1 Previous Clinical Trials
225 Total Patients Enrolled

Media Library

Savolitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03598244 — Phase 1
Primary Central Nervous System Neoplasm Research Study Groups: Treatment (volitinib)
Primary Central Nervous System Neoplasm Clinical Trial 2023: Savolitinib Highlights & Side Effects. Trial Name: NCT03598244 — Phase 1
Savolitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03598244 — Phase 1

Frequently Asked Questions

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

In how many locations are researchers conducting this experiment?

"This research study is primarily based at Lucile Packard Children's Hospital Stanford University in Palo Alto, California, Children's Hospital Colorado in Aurora, Colorado and Nationwide Children's Hospital in Columbus, Ohio; however there are also other 10 sites participating."

Answered by AI

What is the primary goal of this clinical investigation?

"This medicinal trial, which will be monitored for up to a month post-treatment, seeks to ascertain the appropriate phase II dosage. Secondary objectives encompass population parameters (which can be estimated using nonlinear mixed effects modeling methods), objective responses by dose and histology, as well as pharmacokinetic assessments such as volume of central compartment, elimination rate constant, half-life, apparent oral clearance and area under plasma concentration time curve (all of these can be deduced via compartmental methods). Additionally one-way ANOVA analysis on normalized doses shall determine proportionality in kinetic parameters."

Answered by AI

Has Savolitinib been investigated in any prior investigations?

"At present, there are 17 underway trials for Savolitinib with 5 of them in the third phase. Though numerous research centers for this medication exist in Westerville, Ohio, it is available at 1156 other medical facilities as well."

Answered by AI

Does this experiment provide opportunities for geriatric individuals to participate?

"Those that wish to be part of this clinical trial must fall between the ages 6 and 21. There are 556 medical trials currently recruiting for minors, while 3264 studies focus on individuals aged 65 or older."

Answered by AI

Has Savolitinib attained the endorsement of the Food and Drug Administration?

"The safety of Savolitinib has not been fully evaluated, thus receiving a score of 1. This is because this trial is only in Phase 1 - meaning that there are limited studies to support its efficacy and security."

Answered by AI

Are there any remaining slots available for participants in this research?

"Affirmative. The clinicaltrials.gov webpage attests that this medical experiment is currently enrolling participants, having been first posted on October 15th 2018 and last revised on the 19th of October 2022. 50 people are being sought from 10 different sites for involvement in the trial."

Answered by AI

Is this the pioneering iteration of such an experiment?

"Currently, 17 trials are underway for the drug Savolitinib across 415 cities and 34 countries. The first trial of its kind was initiated by AstraZeneca in 2014 which concluded Phase 2 approval with 999 participants. In the intervening years, 16 more have been conducted accordingly."

Answered by AI

What is the sample size for this investigation?

"Affirmative. According to clinicaltrials.gov, this medical research is currently enrolling participants from 10 different sites and requires 50 individuals in total to participate. The trial was initially launched on October 15th, 2018 and has been updated as recently as the 19th of October 2022."

Answered by AI

Who can participate in this research project?

"Eligibility criteria for this medical trial necessitates that patients have a diagnosis of medulloblastoma and be between the ages 6 to 21. The study plans on recruiting up to 50 people."

Answered by AI
~6 spots leftby Jan 2025