NCT05432518

Pilot Trial for Treatment of Recurrent Glioblastoma

Biomarker and Tumor Cell Culture-Driven Pilot Trial for Treatment of Recurrent Glioblastoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a single-arm open-label prospective pilot feasibility trial recruiting 10 adult patients with recurrent glioblastoma who are assigned to receive the personalized study treatment based on the genetic profile of their recurrent GBM tumor resected at the time of surgery. It will be aimed to gather preliminary information on the study intervention and the feasibility of conducting a full-scale trial.

Conditions

• Glioblastoma
• Recurrent Disease
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Afatinib	Afatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.
DRUG	Dasatinib	Dasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.
DRUG	Palbociclib	Palbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.
DRUG	Everolimus	Everolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.
DRUG	Olaparib	Olaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.

Timeline

• Start date: 2023-06-27
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2022-06-27
• Last updated: 2025-04-25

Locations

1 site across 1 country: Canada