Afatinib Expanded Access Program

Expanded access Approved for marketing Boehringer Ingelheim

Summary

This is an open-label, multi-center, single-arm trial, designed to provide early access to afatinib and to provide additional information on the safety and efficacy of afatinib in advanced NSCLC patients who harbor an EGFR mutation.

Timeline

Start: 2012-07
Primary completion: 2014-03
Completion: 2014-03

Publications

Kim ES, Halmos B, Kohut IF, Patel T, Rostorfer RD, Spira AI, Cseh A, McKay J, Wallenstein G, Mileham KF. Efficacy and Safety Results of the Afatinib Expanded Access Program. Oncol Ther. 2017;5(1):103-110. doi: 10.1007/s40487-017-0043-5. Epub 2017 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	20 mg	Oral
Subject	Afatinib	Small molecule	30 mg	Oral
Subject	Afatinib	Small molecule	40 mg	Oral

Afatinib Expanded Access Program

Summary

Timeline

Publications

Drugs

Indications