drugset / Trial / NCT01147211

Dose Defining Study For MK-2206 Combined With Gefitinib In Non Small Cell Lung Cancer (NSCLC)

NCT01147211

Phase 1 Unknown 21 enrolled National Taiwan University Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I study of MK2206 (an AKT inhibitor)and gefitinib in nonsmall cell lung cancer patients who failed prior chemotherapy and epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The patient population is enriched for EGFR mutations. The purpose of this study is to determine whether it is safe to administered MK-2206 in combination with gefitinib in adult patients with locally advanced or metastatic non-small cell lung cancer. The second purpose of this study is to define the MTD (Maximum Tolerated Dose) of MK-2206 when combined with gefitinib. A standard 3-3 dose escalation scheme of MK-2206 with fix dose gefitinib is used in this study.

Timeline

Start
2010-09
Primary completion
2013-07
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-2206 Small molecule 90 mg Oral
Subject MK-2206 Small molecule 135 mg Oral
Background Gefitinib Small molecule 250 mg