Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Pancreatic Neoplasms

Pancreatic Cancer

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Trametinib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Part 1-Dose escalation will be conducted to assess PK after single dosing and safety, tolerability, PK and efficacy of GSK1120212 in Japanese subjects with solid tumors using a continuous daily dosing schedule.

Part 2-Further evaluate the safety, tolerability, PK, and efficacy of GSK1120212 in combination with gemcitabine in subjects with non-small cell lung cancer, pancreatic cancer, biliary cancer, urothelial cancer or other tumor types for which 4-week schedule of gemcitabine has been approved using the recommended dose from Part 1 (single agent).

GSK1120212

GSK Clinical 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.

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.

Trial of GSK1120212 and GSK1120212 in Combination With GEM in Japanese Subjects With Solid Tumors

A Phase I Trial of GSK1120212 and GSK1120212 in Combination With Gemcitabine in Japanese Subjects With Solid Tumors

Individual subject parameter values as well as a descriptive summary (mean, standard deviation, median, minimum, maximum, geometric mean, and the standard deviation, CV% and 95% confidence interval of log-transformed parameters) by dose cohort will be reported.

GlaxoSmithKline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of GSK1120212 and GSK1120212 in Combination With GEM in Japanese Subjects With Solid Tumors	NCT01324258	Solid Tumours	GSK1120212 Gemcitabine	20 Years -	GlaxoSmithKline
Trial of GSK1120212 and GSK1120212 in Combination With GEM in Japanese Subjects With Solid Tumors	NCT01324258	Solid Tumours	GSK1120212 Gemcitabine	20 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for biliary cancer (combination with gemcitabine)