A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)

Phase 1 Terminated 33 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will assess the safety, tolerability, and the maximum tolerated dose (MTD) of MK-2206 in combination with both trastuzumab and trastuzumab/lapatinib in participants with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and other solid tumors. The primary hypothesis of this study is that the combination of oral MK-2206 with trastuzumab or with trastuzumab/lapatinib will be well tolerated in participants with advanced HER2+ solid tumors.

Timeline

Start: 2009-09-15
Primary completion: 2011-08-09
Completion: 2011-12-22

Publications

Results Hudis C, Swanton C, Janjigian YY, Lee R, Sutherland S, Lehman R, Chandarlapaty S, Hamilton N, Gajria D, Knowles J, Shah J, Shannon K, Tetteh E, Sullivan DM, Moreno C, Yan L, Han HS. A phase 1 study evaluating the combination of an allosteric AKT inhibitor (MK-2206) and trastuzumab in patients with HER2-positive solid tumors. Breast Cancer Res. 2013 Nov 19;15(6):R110. doi: 10.1186/bcr3577.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	500 mg	Oral
Subject	Lapatinib	Small molecule	750 mg	Oral
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	MK-2206	Small molecule	45 mg	Oral
Subject	MK-2206	Small molecule	60 mg	Oral
Subject	MK-2206	Small molecule	135 mg	Oral
Subject	MK-2206	Small molecule	200 mg	Oral
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)

Summary

Timeline

Publications

Drugs

Indications