NCT01520870

Safety and Efficacy of PF-299804 (Dacomitinib), a Pan-HER Irreversible Inhibitor, in Patients With Recurrent Glioblastoma With EGFR Amplification or Presence of EGFRvIII Mutation. A Phase II CT.

Phase II Pilot, Prospective, Open Label, Multicenter CT, to Evaluate the Safety and Efficacy of PF299804, a Pan-HER Irreversible Inhibitor, in Patients With Recurrent Glioblastoma With EGFR Amplification or Presence of EGFRvIII Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Grupo Español de Investigación en Neurooncología · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, 2-stage, open-label, phase II trial aims to assess the efficacy and safety of dacomitinib in adult patients with recurrent Glioblastoma (GBM) with EGFR gene amplification and/or EGFRvIII mutation.

Conditions

• Glioblastoma
• Brain Tumor, Recurrent

Interventions

Type	Name	Description
DRUG	PF-299804 (Dacomitinib)	Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end.

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-04-01
• Completion: 2017-03-09
• First posted: 2012-01-30
• Last updated: 2021-07-06
• Results posted: 2021-07-06

Locations

12 sites across 1 country: Spain