NCT01235897

MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies

A Phase Ib Dose-escalation Trial of the AKT Inhibitor MK2206 in Combination With Weekly Paclitaxel With or Without Trastuzumab

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and safest highest dose of an investigational drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.

Detailed description

The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of MK-2206 in combination with paclitaxel and trastuzumab when given to patients with HER2-overexpressing solid tumor malignancies. MK-2206 is an oral drug (taken by mouth) that turns off a protein called AKT inside cancer cells. This could be helpful in treating treatment-resistant cancers, because AKT allows cells to survive despite active anticancer treatment. In the case of HER2-positive cancers, laboratory studies suggest that the drug combination of MK-2206 and paclitaxel and trastuzumab may be effective.

Conditions

• Advanced Solid Tumors
• Tumors
• Cancer

Interventions

Type	Name	Description
DRUG	MK-2206	Different dose levels of MK-2206 will studied, and co-administered with paclitaxel and trastuzumab. MK-2206 will be given orally with a starting dose of 135 mg weekly
DRUG	Paclitaxel	80 mg/m2 weekly - paclitaxel
DRUG	Trastuzumab	2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-03-01
• Completion: 2013-11-01
• First posted: 2010-11-08
• Last updated: 2014-04-17
• Results posted: 2013-11-19

Locations

1 site across 1 country: United States