Your session is about to expire
← Back to Search
Savolitinib for Brain Tumors
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- 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.
- Group 1: Treatment (volitinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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."
Share this study with friends
Copy Link
Messenger