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Proprotein Convertase/Kexin Type 9 Serine Protease Inhibitor
Evolocumab for Brain Cancer
Phase < 1
Recruiting
Led By Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with newly diagnosed or recurrent high grade glioma (HGG) or glioblastoma (GBM) with prior pathology report indicating HGG or GBM
Adequate hepatic function within 14 days prior to starting evolocumab: Total bilirubin ≥ 1.5 x institutional upper limit of normal (ULN), AST(SGOT) and ALT(SGPT) ≥ 1.5 × ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgical resection
Awards & highlights
Study Summary
This trialwill test if a type of drug can cross the blood-brain barrier and be used to treat brain cancer.
Who is the study for?
Adults over 18 with high grade glioma or glioblastoma, either newly diagnosed or recurrent. They must have good blood counts, kidney and liver function, and not be severely hepatically impaired. Women of childbearing potential need a negative pregnancy test and all participants must agree to effective birth control.Check my eligibility
What is being tested?
The trial is testing if the FDA-approved drug Evolocumab can cross the blood-brain barrier in patients with malignant brain tumors. It's a Phase 0 study focusing on how the body processes the drug and its effects on tumor tissue.See study design
What are the potential side effects?
Specific side effects for this trial are not listed but generally, Evolocumab may cause reactions at injection sites, cold-like symptoms, back pain, and rarely more serious allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a high-grade brain tumor.
Select...
My liver tests are within the required range for starting evolocumab.
Select...
My kidney function is good enough for treatment, based on a recent test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of surgical resection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgical resection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence of evolocumab in surgical tumor tissue and tissue from a matched control group
Secondary outcome measures
Correlation between serum and surgical tumor tissue levels of evolocumab
Lipids
Body tissue
Side effects data
From 2020 Phase 4 trial • 259 Patients • NCT030962885%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single dose of evolocumabExperimental Treatment1 Intervention
420 mg of evolocumab subcutaneous injection 7-14 days before scheduled surgery for malignant glioma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
2011
Completed Phase 4
~13010
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,476 Total Patients Enrolled
Mustafa Khasraw, MBChB, MD, FRCP, FRACPPrincipal InvestigatorDuke University
6 Previous Clinical Trials
205 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a stroke or eye bleeding unrelated to cancer surgery in the last 6 months.I finished IV antibiotics for an infection less than a week ago, except for preventive reasons.My liver function is not severely impaired.I have been diagnosed with a high-grade brain tumor.I am 18 years old or older.My liver tests are within the required range for starting evolocumab.My kidney function is good enough for treatment, based on a recent test.I agree to use effective birth control during and up to 1 month after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Single dose of evolocumab
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.
Is this a pioneering endeavor in the medical field?
"Developed by Hoffmann-La Roche, Evolocumab has been under clinical study since 2018. After a successful initial trial involving 435 participants, the drug received Phase 1 and 2 approval from regulators. Currently, 22 active trials are ongoing in 240 cities across 35 nations."
Answered by AI
Are there available vacancies in this experiment for volunteers?
"The clinical trial, initially posted on October 8th 2021, is still searching for suitable patients according to the data found on clinicaltrials.gov. This information has been recently updated by our team as of October 13th 2022."
Answered by AI
Approximately how many individuals are being admitted to participate in this research?
"Correct. Clinicaltrials.gov indicates that this clinical trial, which was issued on October 8th 2021, is actively recruiting patients. The research is trying to find 10 individuals at a single site."
Answered by AI
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