A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)

Phase 1 Completed 77 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors. The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.

Timeline

Start: 2009-03-17
Primary completion: 2011-05-19
Completion: 2012-05-17

Publications

Molife LR, Yan L, Vitfell-Rasmussen J, Zernhelt AM, Sullivan DM, Cassier PA, Chen E, Biondo A, Tetteh E, Siu LL, Patnaik A, Papadopoulos KP, de Bono JS, Tolcher AW, Minton S. Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors. J Hematol Oncol. 2014 Jan 3;7:1. doi: 10.1186/1756-8722-7-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-2206	Small molecule	30 mg	Oral
Subject	MK-2206	Small molecule	45 mg	Oral
Subject	MK-2206	Small molecule	60 mg	Oral
Subject	MK-2206	Small molecule	90 mg	Oral
Subject	MK-2206	Small molecule	135 mg	Oral
Subject	MK-2206	Small molecule	200 mg	Oral
Subject	MK-2206	Small molecule	250 mg	Oral
Background	Carboplatin	Small molecule	—	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Erlotinib	Small molecule	100 mg	Oral
Background	Erlotinib	Small molecule	150 mg	Oral
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous

Indications

No indication recorded.