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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00687622 |
Purpose
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 Solid Tumours |
Drug: GSK1120212 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 94 |
| Study Start Date: | July 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GSK1120212
Part 1 will identify the maximum tolerated dose using a dose-escalation procedure. Part 2 will explore further the safety, tolerability, and clinical activity of GSK1120212 in subjects with pancreatic, melanoma, non-small cell lung, and KRAS or BRAF mutation-positive colorectal cancer. Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic markers in tumor tissue
|
Drug: GSK1120212
Part 1-dose-escalation Part 2 - Recommended Part 2 dose Part 3 - characterize the range of biologically effective doses
Other Name: GSK1120212
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Part 1
A female subject is eligible to participate if she is of:
Part 2 - As per Part 1 with the exception of criterion 3 and:
Part 3 - As per Part 1 and:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| GSK Investigational Site | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| GSK Investigational Site | |
| Ft. Myers, Florida, United States, 33905 | |
| GSK Investigational Site | |
| Ocoee, Florida, United States, 34761 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89169 | |
| United States, New York | |
| GSK Investigational Site | |
| Albany, New York, United States, 12206 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Kettering, Ohio, United States, 45409 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00687622 History of Changes |
| Other Study ID Numbers: | MEK111054 |
| Study First Received: | May 28, 2008 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
MEK inhibitor solid tumors First Time in Human |
GSK1120212 Oncology melanoma |
|
Lymphoma Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |