Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Summary

This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may kill more tumor cells.

Timeline

Start

2007-01

Primary completion

2009-08

Completion

2009-08

Outcome

Missed primary endpoint

registry Treatment; p = 0.4; Hazard Ratio (HR) 0.85 (95% CI 0.6 to 1.3) NCT00445588 ↗

paper The study did not meet its objective of a 30% increase in overall survival time compared with historical controls. PMID 23328813 ↗

Publications

• Results Peereboom DM, Ahluwalia MS, Ye X, Supko JG, Hilderbrand SL, Phuphanich S, Nabors LB, Rosenfeld MR, Mikkelsen T, Grossman SA; New Approaches to Brain Tumor Therapy Consortium. NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme. Neuro Oncol. 2013 Apr;15(4):490-6. doi: 10.1093/neuonc/nos322. Epub 2013 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Sorafenib	Small molecule	400 mg	Oral

Indications