Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Phase 1 Completed 63 enrolled Puma Biotechnology, Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.

Timeline

Start: 2009-04
Primary completion: 2011-06
Completion: 2013-12

Publications

Gandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10;32(2):68-75. doi: 10.1200/JCO.2012.47.2787. Epub 2013 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neratinib	Small molecule	120 mg	Oral
Subject	Neratinib	Small molecule	160 mg	Oral
Subject	Neratinib	Small molecule	200 mg	Oral
Subject	Neratinib	Small molecule	240 mg	Oral
Subject	Temsirolimus	Small molecule	15 mg	Intravenous
Subject	Temsirolimus	Small molecule	25 mg	Intravenous
Subject	Temsirolimus	Small molecule	50 mg	Intravenous
Subject	Temsirolimus	Small molecule	75 mg	Intravenous

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications