Spots Global Cancer Trial Database for Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias
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Trial Identification
Brief Title: Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias
Official Title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias
Study ID: NCT00920140
Conditions
Study Description
Brief Summary: MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose escalations will continue based on predefined parameters until a maximum tolerated dose is established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or refractory leukaemias (AML, MDS or CMML) will be determined.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Birmingham, Alabama, United States
GSK Investigational Site, Duarte, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, San Francisco, California, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Rochester, Minnesota, United States
GSK Investigational Site, Bornx, New York, United States
GSK Investigational Site, Lake Success, New York, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Winston-Salem, North Carolina, United States
GSK Investigational Site, Portland, Oregon, United States
GSK Investigational Site, Hershey, Pennsylvania, United States
GSK Investigational Site, Pittsburgh, Pennsylvania, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Seattle, Washington, United States
GSK Investigational Site, Gent, , Belgium
GSK Investigational Site, Leuven, , Belgium
GSK Investigational Site, Bobigny Cedex, , France
GSK Investigational Site, Lille cedex, , France
GSK Investigational Site, Marseille Cedex 09, , France
GSK Investigational Site, Pierre-Bénite cedex, , France
GSK Investigational Site, Toulouse cedex 9, , France
GSK Investigational Site, Frankfurt, Hessen, Germany
GSK Investigational Site, Duisburg, Nordrhein-Westfalen, Germany
GSK Investigational Site, Muenster, Nordrhein-Westfalen, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz, Germany
GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Leipzig, Sachsen, Germany
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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