Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme

Phase 2 Completed 32 enrolled Duke University Genentech, Inc. · collab OSI Pharmaceuticals · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary objective: To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus. Secondary objectives: To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and to evaluate progression free survival, radiographic response and overall survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

Timeline

Start: 2007-04
Primary completion: 2008-09
Completion: 2009-12

Publications

Results Reardon DA, Desjardins A, Vredenburgh JJ, Gururangan S, Friedman AH, Herndon JE 2nd, Marcello J, Norfleet JA, McLendon RE, Sampson JH, Friedman HS. Phase 2 trial of erlotinib plus sirolimus in adults with recurrent glioblastoma. J Neurooncol. 2010 Jan;96(2):219-30. doi: 10.1007/s11060-009-9950-0. Epub 2009 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Erlotinib	Small molecule	400 mg	Oral
Subject	Sirolimus	Small molecule	5 mg	Oral
Subject	Sirolimus	Small molecule	10 mg	Oral

Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme

Summary

Timeline

Publications

Drugs

Indications