Solid Tumours Clinical Trial
Official title:
A Phase I Trial of GSK1120212 and GSK1120212 in Combination With Gemcitabine in Japanese Subjects With Solid Tumors
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.
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.
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