Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors

Inclusion Criteria:

- Age ≥ 18 years

- Metastatic colorectal cancer

- Progression on or following standard therapy, or no standard therapy (phase Ib).
Progression on or following at least 2-prior fluoropyrimidine-containing chemotherapy
regimens (phase II)

- Written documentation of mutant or wild-type RAS

- Life expectancy ≥ 3 months

- ECOG performance status ≤ 2

Exclusion Criteria:

Phase II arms 1 and 4 only: previous treatment with cetuximab, panitumumab, and/or other
EGFR inhibitors

- Previous treatment with MEK-inhibitors

- History of severe infusion reactions to monoclonal antibodies.

- Symptomatic or untreated leptomeningeal disease

- Symptomatic brain metastasis

- Current evidence of retinal disease; history of CSR, RVO or ophthalmopathy as
assessed by ophthalmologic examination at baseline that would be considered a risk
factor for CSR/RVO and history of keratitis.

- Acute or chronic pancreatitis

- Clinically significant cardiac disease

- Not adequate hematologic, renal and hepatic function