A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 93
- Locations
- 10
- Primary Endpoint
- Establish the maximum tolerated dose (MTD) of the study drug.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ARRY-438162 (MEK 162)
Intervention: ARRY-438162 (MEK162), MEK inhibitor; oral (Drug)
Outcomes
Primary Outcomes
Establish the maximum tolerated dose (MTD) of the study drug.
Time Frame: Part 1, one year
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame: Parts 1, 2 and 3: two years
Characterize the pharmacokinetics (PK) of the study drug and metabolite.
Time Frame: Parts 1, 2 and 3: two years
Secondary Outcomes
- Assess the efficacy of the study drug in terms of tumor response, duration of response, duration of stable disease, progression-free survival and overall survival.(Parts 1, 2 and 3: two years)
- Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations.(Parts 1, 2 and 3: two years)