Your session is about to expire
← Back to Search
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 belowSelect...
I can swallow whole tablets.
Select...
My blood, liver, kidney, and heart are functioning within normal ranges.
Select...
I meet the requirements for a stem cell transplant.
Select...
My physical ability is rated by a doctor's scale.
Select...
My kidney function tests are within the normal range for my age and gender.
Select...
My brain tumor has come back, is not responding, or is getting worse.
Select...
I am between 5 and 21 years old.
Select...
My body size meets the specific requirements for the trial's dose levels.
Select...
My heart is functioning within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreTrial 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
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Savolitinib
2019
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,718 Previous Clinical Trials
40,963,341 Total Patients Enrolled
Ralph SalloumPrincipal InvestigatorPediatric Brain Tumor Consortium
1 Previous Clinical Trials
225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow whole tablets.My blood, liver, kidney, and heart are functioning within normal ranges.I recently completed a specific type of radiation therapy.I've had treatment for my cancer before, but it didn't work, and I've recovered from any major side effects.I do not have any major illnesses or organ problems unrelated to my cancer.I am currently on other treatments.My physical ability is rated by a doctor's scale.I have a heart condition.I have been on a stable or decreasing dose of corticosteroids for at least a week.I am on a stable dose of blood thinner for my clot.I do not have another cancer that could affect this treatment's safety or results.My brain tumor is growing or returning and has a specific genetic change.I haven't taken any colony-stimulating factors in the last week.I am eligible regardless of my gender, race, or ethnicity.My kidney function tests are within the normal range for my age and gender.My brain tumor has come back, is not responding, or is getting worse.I am between 5 and 21 years old.My body size meets the specific requirements for the trial's dose levels.My neurological symptoms have been stable for at least a week.I meet the requirements for a stem cell transplant.My high blood pressure is not under control.I have recovered from side effects of previous cancer treatments.I currently have a serious infection.I received my last cancer treatment affecting my bone marrow over 3 weeks ago.My heart is functioning within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (volitinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger