drugset / Trial / NCT01147211
Dose Defining Study For MK-2206 Combined With Gefitinib In Non Small Cell Lung Cancer (NSCLC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-2206 | Small molecule | 90 mg | Oral |
| Subject | MK-2206 | Small molecule | 135 mg | Oral |
| Background | Gefitinib | Small molecule | 250 mg | — |