A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
Completed · Phase 1
Conditions studied: Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer
In brief
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162). This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1. (Active, not recruiting) In the second part of the study, patients with advanced or metastatic biliary cancer will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not recruiting) In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive the best dose of the study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15 patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.
Key facts
- Study ID
- NCT00959127
- Run by
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- People needed
- 93
- Starts
- 2009-08-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2020-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
- Dana-Farber/Harvard Cancer Center — Boston, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Ohio State University — Columbus, Ohio, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.