Overview

Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform

Status:
Completed

Trial end date:
2017-09-12

Target enrollment:

Participant gender:

Summary

This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD), safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor receptor(EGFR)inhibitor) to be used in combination with: - radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator) or - radiotherapy and Temozolomide (in patients with a methylated (silenced) O6-methylguanine-DNA methyltransferase gene (MGMT) to treat newly diagnosed patients with Grade IV Glioblastoma (primary brain cancer).

Phase:

Phase 1

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Afatinib
Dacarbazine
Temozolomide