An Open-label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma

Inclusion Criteria

Inclusion criteria:

- Age ≥ 18 years old and ≤ 65 years old.

- Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or
cytological specimen from original resection of primary tumor.

- Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus
bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.

- Patients with at least one measurable lesion by RECIST as determined by Computer
Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.

- Patients with a WHO performance status of 0 or 1.

Exclusion criteria:

- Patients with Gilbert's syndrome or any other syndrome associated with deficient
glucoronidation of bilirubin.

- Patients who are homozygous for the UGT1A1*28 allele as determined by sequencing.

- Patients who have received previous irinotecan-based therapy.

- Prior treatment with an mTOR inhibitor.

Other protocol-defined inclusion/exclusion criteria may apply