A Single Arm, Multicenter Phase II Study of Everolimus in Patients With Metastatic Colorectal Adenocarcinoma Whose Cancer Has Progressed Despite Prior Therapy With an Anti-EGFR Antibody (if Appropriate), Bevacizumab, Fluoropyrimidine, Oxaliplatin, and Irinotecan-based Regimens

Inclusion Criteria

Inclusion criteria:

- Age ≥ 18 years old.

- Patients with metastatic colorectal cancer (CRC).

- Patients must have sufficient and obtainable tumor tissue for biomarker analysis from
original surgical resection.

- Patients with documented disease progression within 6 months of their most recent
dose of chemotherapeutic regimens.

- Patients with at least one measurable lesion.

- Adequate bone marrow function.

- Adequate liver function.

- Adequate renal function.

- Patients with a life expectancy of > 3 months.

- Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.

- Women of childbearing potential must have had a negative serum pregnancy test 72
hours prior to the administration of the first study treatment.

- Patients who give a written informed consent obtained according to local guidelines.

Exclusion criteria:

- Patients currently receiving anti-cancer agents or who have received these within 4
weeks prior to study entry.

- Patients who have previously received RAD001.

- Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus,
temsirolimus) or to its excipients.

- Chronic treatment with steroids or another immunosuppressive agent.

- Patients with untreated central nervous system (CNS) metastases or neurologically
unstable CNS metastases.

- HIV seropositivity.

- Patients with an active, bleeding diathesis. Patients may use enoxaparin.

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study.

- Patients who have a history of another primary malignancy < 3 years, with the
exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.

- Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods.

- Patients who are using other investigational agents or who had received
investigational drugs ≤ 4 weeks prior to first study treatment.

- Patients unwilling to or unable to comply with the protocol.

Other protocol defined inclusion/exclusion criteria may apply