NCT03965494

AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery

Pilot Surgical PK Study of BGB324 in Recurrent Glioblastoma Patients

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies how well AXL inhibitor BGB324 works in treating participants with glioblastoma that has come back who are undergoing surgery. AXL inhibitor BGB324 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the penetration of AXL inhibitor BGB324 (BGB324) across the blood brain barrier measured by pharmacokinetics/drug concentration of 1.0 uM in tissue resected from a contrast enhancing region of the tumor in 60% of recurrent glioblastoma patients. SECONDARY OBJECTIVES: I. Determine AXL expression, phosphorylation state (AXL phosphospecific antibody if AXL is inhibited), and circulating soluble AXL levels. II. Determine the BGB324 concentration in tissue resected from a contrast non-enhancing region of the tumor. III. Characterize the steady state pharmacokinetics of BGB324 in patients with recurrent glioblastoma. IV. Estimate safety and tolerability of BGB324 for recurrent glioblastoma. V. Assess the progression-free and overall survival of patients with recurrent glioblastoma. OUTLINE: Participants are assigned to 1 of 2 groups. GROUP A: Participants receive AXL inhibitor BGB324 orally (PO) once daily (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. GROUP B: 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. After completion of study treatment, participants are followed up at 30 days.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	BGB 324 (before surgery)	Given by mouth either BEFORE therapeutic conventional surgery
DRUG	BGB 324 (after surgery)	Given by mouth either AFTER therapeutic conventional surgery

Timeline

• Start date: 2020-01-02
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2019-05-29
• Last updated: 2024-02-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study