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Brief Title: A Study of the Safety and Activity of the MEK Inhibitor Given Together With the AKT Inhibitor to Patients With Multiple Myeloma or Solid Tumor Cancers
Official Title: An Open-Label, Two Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination With the AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Multiple Myeloma
Study ID: NCT01476137
Brief Summary: The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor can be given in combination and if the combination is effective treatment for patients with solid tumors, including breast cancer and endometrial cancer, and for patients with multiple myeloma.
Detailed Description: This is an open-label, two part, Phase I/II study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of the MEK inhibitor GSK1120212 administered in combination with the AKT inhibitor GSK2110183 in subjects with solid tumors and multiple myeloma. In Part 1, the safety and tolerability of a range of doses for GSK1120212 and GSK2110183 dosed in combination will be investigated; pharmacokinetics will also be analyzed to determine whether there is a drug-drug interaction between GSK1120212 and GSK2110183 when dosed in combination. The second part of the study will focus on evaluation of the clinical efficacy of the combination as well as the pharmacodynamic response in subjects with proteasome-refractory multiple myeloma (Part 2A) or solid tumors, putatively endometrial and triple negative breast cancer (Part 2B).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Dallas, Texas, United States
GSK Investigational Site, San Antonio, Texas, United States
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR