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Kinase Inhibitor
Avutometinib + Defactinib for Glioblastoma
Phase < 1
Recruiting
Led By Jeffrey J Olson, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgery
Awards & highlights
Study Summary
This trial tests two drugs to stop glioblastoma growth by regulating chemical reactions in cells.
Who is the study for?
Adults over 21 with new or recurrent glioblastoma who are undergoing surgery can join. They must be relatively healthy, with good organ function and blood counts, not have severe heart or lung conditions, no active hepatitis B/C or HIV, and agree to use effective contraception. Pregnant women, prisoners, those on certain drugs that interact with the trial medications, and minors are excluded.Check my eligibility
What is being tested?
The trial is testing how much of two new drugs (Defactinib and VS-6766) gets into the brain and their safety in treating glioblastoma. These drugs target different growth pathways in tumor cells which may help stop tumor growth when used together.See study design
What are the potential side effects?
Potential side effects include reactions related to kinase inhibitors such as fatigue, nausea, diarrhea; liver issues; changes in blood pressure; possible heart rhythm abnormalities; muscle pain or weakness could occur due to drug interactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks post surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of avutometinib (VS-6766) that accumulates in the GBM and brain around tumor
Concentration of defactinib that accumulates in the glioblastoma (GBM) and brain around tumor
Incidence of adverse events associated with VS-6766
+1 moreSecondary outcome measures
MEK and Erk in tumor, brain around tumor, and serum
Pyk2 and FAK phosphorylation in tumor, brain around tumor, and serum
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (Avutometinib)Experimental Treatment2 Interventions
Patients receive 1 dose of avutometinib PO while on study, prior to planned tumor resection. Patients undergo blood collection and donate resected tumor tissue while on study.
Group II: Arm I (Defactinib)Experimental Treatment2 Interventions
Patients receive 1 dose of defactinib PO while on study, prior to planned tumor resection. Patients undergo blood collection and donate resected tumor tissue while on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defactinib
2013
Completed Phase 1
~60
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,645 Total Patients Enrolled
11 Trials studying Glioblastoma
336 Patients Enrolled for Glioblastoma
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,586 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,429 Total Patients Enrolled
323 Trials studying Glioblastoma
23,136 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before, but it was either cured or is unlikely to come back.I have an active hepatitis B, C, or HIV infection needing treatment.I have an eye condition.I do not have major stomach issues, blood clotting treatments, or serious heart/lung problems.I have a new or returning brain tumor that needs surgery.I am older than 21 years.I am an adult.I do not have severe heart or lung conditions.I haven't had any cancer treatment in the last 4 weeks.I can carry out all my usual activities without help.My kidney function, measured by creatinine clearance, is adequate.I have mostly recovered from side effects of previous treatments, except for hair loss or mild nerve damage.I have had a skin condition that needed treatment through pills or injections in the last year.My hemoglobin level is stable and above 9.0 g/dL.My heart's electrical activity is within a safe range.I haven't taken any medications or supplements that could interact with VS-6766 in the last 14 days.I agree to use effective birth control during and after the trial as required.I haven't had major surgery in the last 4 weeks, minor surgery in the last 2 weeks, or palliative radiotherapy in the last week.I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.I have had rhabdomyolysis in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (Avutometinib)
- Group 2: Arm I (Defactinib)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment slots still available for this experiment?
"Clinicaltrials.gov data suggests that this medical trial is not accepting participants currently, as the last update was done on March 22nd 2023 since its initial posting in April 15th of that same year. However, 463 other trials are still actively recruiting subjects at this time."
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