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BGB 324 (after surgery) for Brain Tumor

Phase < 1
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 up to 1 year
Awards & highlights

Study Summary

This trial is testing an AXL inhibitor to see if it can stop the growth of glioblastoma cells.

Eligible Conditions
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients who achieve a drug concentration at >= 1.0 uM level in contrast enhancing tumor tissue
Secondary outcome measures
Change in AXL expression level
Overall survival
Pharmacokinetics as measured by area under the curve (AUC) (ug/mL*hr)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Surgery then AXL inhibitor BGB324Experimental Treatment1 Intervention
Participants undergo surgery, then within 45 days receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: AXL inhibitor BGB324 then surgeryExperimental Treatment1 Intervention
Participants receive AXL inhibitor BGB324 PO QD on days 1-5, then undergo surgery 3-6 hours after last dose. Within 45 days, participants receive AXL inhibitor BGB324 PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,890 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,143 Total Patients Enrolled
BerGenBio ASAIndustry Sponsor
13 Previous Clinical Trials
887 Total Patients Enrolled

Media Library

BGB 324 (after surgery) Clinical Trial Eligibility Overview. Trial Name: NCT03965494 — Phase < 1
Brain Tumor Research Study Groups: AXL inhibitor BGB324 then surgery, Surgery then AXL inhibitor BGB324
Brain Tumor Clinical Trial 2023: BGB 324 (after surgery) Highlights & Side Effects. Trial Name: NCT03965494 — Phase < 1
BGB 324 (after surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03965494 — Phase < 1

Frequently Asked Questions

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

Are there any open enrolment opportunities for this clinical trial?

"As indicated on clinicaltrials.gov, this medical trial is not currently enrolling patients; it was initially published on the 2nd of January 2020 and last edited in December 1st 2022. However, there are still 547 active trials recruiting participants at present."

Answered by AI

What is the number of enrollees currently involved in this research?

"Unfortunately, this medical study is not currently accepting participants. Initially posted on February 1st 2020 and last updated December first 2022, if you are looking for alternatives there are 543 trials recruiting patients with central nervous system neoplasms and 4 studies actively enrolling those who have gone through surgery to receive BGB 324."

Answered by AI

Does the age criterion for this exploration extend to octogenarians?

"As per the specifications of this clinical trial, individuals aged 18 and above but below 120 years old are eligible to take part."

Answered by AI

How many healthcare facilities are presently executing this trial?

"Currently, 8 sites are conducting this clinical trial; some of these include New york, Detroit and Baltimore. To reduce travel demands for patients enrolled in the study, it would be beneficial to choose a location nearest you."

Answered by AI

Are there any reports of post-operative studies with BGB 324?

"BGB 324's initial investigations began in 2016 at the University of Texas Southwestern Medical Center. Since then, 3 trials have been finalized, and there are now 4 live studies centered around New york City."

Answered by AI

Has this type of clinical trial been conducted before?

"Since 2016, BGB 324 (after surgery) has been studied in numerous clinical trials. The initial trial was backed by BerGenBio ASA and had 23 participants; it eventually led to the drug being approved for Phase 1 use. Currently, there are 4 ongoing studies on the medication across 9 cities distributed over 3 countries."

Answered by AI

Is enrollment still open for the clinical trial?

"This trial is open to 20 individuals over 18 years old suffering from central nervous system neoplasms. Applicants must have experienced no more than two previous recurrences, and be 12 weeks removed from radiation therapy, 4 weeks away from investigational agents not sanctioned by the FDA, as well as certain antiangiogenesis drugs (bevacizumab, aflibercept, ramucirumab etc.), and 3 weeks distant from non-nitrosourea chemotherapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery
2020. "AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03965494.
~2 spots leftby Apr 2025
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