Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer

Phase 1 Completed 12 enrolled GlaxoSmithKline

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.

Timeline

Start: 2007-09-26
Primary completion: 2008-10-31
Completion: 2008-10-31

Publications

Dennie TW, Fleming RA, Bowen CJ, Dar MM, Alberti D, Oliver K, Loconte N, Mulkerin D, Holen KD. A phase I study of capecitabine, oxaliplatin, and lapatinib in metastatic or advanced solid tumors. Clin Colorectal Cancer. 2011 Mar 1;10(1):57-62. doi: 10.3816/CCC.2011.n.008.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1500 mg/m2	Oral
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications