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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

Cancer

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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