A Phase 1 Study of ARRY-438162 (MEK162) in Patients With Advanced Solid Tumors Followed by Expansion Cohorts in Patients With Advanced or Metastatic Biliary Cancer or Metastatic Colorectal Cancer

This is a 3-part study to assess the safety, tolerability, and pharmacokinetics of
ARRY-438162 (MEK162) in patients with advanced solid tumors. The first part is an open-label
dose escalation study to establish the maximum tolerated dose of ARRY-438162 (MEK162).
Approximately 30 patients from the US will be enrolled in Part 1. (Active, Not Recruiting)

The second part, expansion at maximum tolerated dose (MTD), is designed to assess the
safety, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics (PD) in patients with
advanced or metastatic biliary cancer. Approximately 25 patients from the US will be
enrolled in Part 2. (Active, Not Recruiting)

The third part, CRC expansion at MTD is designed to assess the safety, preliminary efficacy,
pharmacokinetics, pharmacodynamics in patients with metastatic colorectal cancer.
Approximately 25 patients with KRAS mutation and 15 patients with BRAF mutation will be
enrolled in the US. (Recruiting)