drugset / Trial / NCT00884416

Sorafenib in Newly Diagnosed High Grade Glioma

NCT00884416 ↗

Phase 1 Completed 17 enrolled University Hospital, Geneva Bayer · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination with Temodar and radiation therapy in patients with newly diagnosed high grade glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes it an interesting drug to investigate in the treatment of patients with high grade glioma as this agent has anti-angiogenic activity and inhibits other pathways such as Ras, Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which are potential targets against gliomas.

Timeline

Start
2009-03
Primary completion
2011-12
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 200 mg Oral
Subject Sorafenib Small molecule 400 mg Oral