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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00687622 |
MEK111054 is a first-time-in-human, open-label study to determine recommended dose and regimen for the orally administered GSK1120212. The study consists of three parts. Part 1 will identify the maximum tolerated dose. Part 2 will explore the safety, tolerability, and effectiveness of GSK1120212. Part 3 will determine a range of effective doses.
Condition | Intervention | Phase |
Solid Tumors and Lymphoma |
Drug: GSK1120212 |
Phase I |
MedlinePlus related topics: | Cancer Lymphoma |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the MEK Inhibitor GSK1120212 in Subjects With Solid Tumors or Lymphoma |
Estimated Enrollment: | 94 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Colorado | |||||
GSK Investigational Site | Not yet recruiting | ||||
Aurora, Colorado, United States, 80045 | |||||
United States, Pennsylvania | |||||
GSK Investigational Site | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Tennessee | |||||
GSK Investigational Site | Recruiting | ||||
Nashville, Tennessee, United States, 37203 |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | MEK111054 |
First Received: | May 28, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00687622 |
Health Authority: | United States: Food and Drug Administration |
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