Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

Phase 1 Completed 48 enrolled Gustave Roussy, Cancer Campus, Grand Paris

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

Timeline

Start: 2005-06
Primary completion: —
Completion: —

Publications

White-Koning M, Civade E, Geoerger B, Thomas F, Le Deley MC, Hennebelle I, Delord JP, Chatelut E, Vassal G. Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children. Clin Cancer Res. 2011 Jul 15;17(14):4862-71. doi: 10.1158/1078-0432.CCR-10-3278. Epub 2011 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	75 mg/m2	—
Subject	Erlotinib	Small molecule	150 mg/m2	—

Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

Summary

Timeline

Publications

Drugs

Indications