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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
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 moreTrial 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.
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,089 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,304 Total Patients Enrolled
BerGenBio ASAIndustry Sponsor
13 Previous Clinical Trials
887 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you are currently taking any other experimental drugs.You have had allergic reactions to similar substances as BGB324 in the past. You can refer to the investigator brochure for more details.You cannot participate if you have a history of a bleeding disorder.You have severe heart failure that causes symptoms even with mild physical activity.You are currently taking a medication that can cause a certain type of heart rhythm problem called torsade de pointes. You will need to stop taking this medication at least two weeks before starting the study treatment.You have a family member or personal history of heart problems that can cause irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: AXL inhibitor BGB324 then surgery
- Group 2: Surgery then AXL inhibitor BGB324
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.
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