Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT01324258
Brief 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.
Detailed 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:
NCT01324258
Study Brief:
Protocol Section:
NCT01324258