Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Inclusion Criteria:

- Locally unresectable or metastatic pancreatic neuroendocrine tumor

- Radiologic, operative, or pathology reports should document a pancreatic location of
tumor

- Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma

- Patients must have at least one measurable site of disease according to RECIST
criteria that has not been preciously irradiated

- 18 years of age or older

- Minimum of two weeks since any major surgery, completion of radiation, or completion
of all prior systemic anticancer therapy

- Prior treatment with chemotherapy is allowed, with the exception of prior treatment
with temozolomide or dacarbazine

- No Prior therapy with RAD001 or any other mTOR inhibitor

- ECOG Performance status 0,1 or 2

- Life expectancy 12 weeks or more

- Adequate bone marrow, liver and renal function as outlined in the protocol

- Negative serum pregnancy test

- Fasting serum cholesterol as outlined in protocol

Exclusion Criteria:

- Prior treatment with any investigational drug within the preceding 4 weeks

- Chronic treatment with systemic steroids or another immunosuppressive agent

- Patients should not receive immunization with attenuated live vaccines during study
period or within 1 week of study entry

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases

- Other malignancies within the past 3 years except for adequately treated carcinoma of
the cervix or basal or squamous cell carcinoma of the skin

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

- Women who are pregnant or breast feeding

- Patients who have received prior treatment with an mTOR inhibitor or temozolomide

- Patients with known hypersensitivity to RAD001 or other rapamycins or to its
excipients

- History of noncompliance to medical regimens