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Clinical Trial Summary

This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This study is designed to identify recommended doses and regimens in Japanese subjects for the future development of GSK1120212.


Clinical Trial Description

GSK1120212 has demonstrated anti-proliferative activity against a broad range of tumors cell lines and xenograft models. To date, MEK inhibitors have demonstrated evidence of both pharmacodynamic and clinical activity in early trials.

This is the first clinical experience in Japan with GSK1120212, a novel MEK inhibitor. This study is designed to identify recommended doses and regimens in Japanese subjects for the future development of GSK1120212.

This study will be conducted in subject with solid tumors, and GSK1120212 single agent treatment to assess safety, tolerability, PK and efficacy (Part 1) and combination treatment with gemcitabine in subjects with non-small cell lung cancer, pancreatic cancer, biliary cancer, urothelial cancer or other tumor types for which gemcitabine has been approved in 4-week schedule to assess safety, tolerability, PK and efficacy(Part 2) will be conducted in the same protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01324258
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date January 24, 2011
Completion date July 8, 2013

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