An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy

Inclusion Criteria

Inclusion criteria for both strata:

- Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor
(NET)

- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma

- Objective disease progression by Response Evaluation Criteria in Solid tumors
(RECIST) criteria while receiving cytotoxic chemotherapy or at any time after
receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive
cycles or months of treatment with the same cytotoxic drug or regimen)

- Presence of at least one measurable disease using RECIST criteria at screening
(computer tomography [CT] or Magnetic resonance imaging [MRI])

- Adequate bone marrow, liver and kidney function

- WHO Performance Status 0-2.

Inclusion criteria for Stratum 2 only:

- Meet all inclusion criteria defined above for both strata.

- Receiving treatment (at least 3 consecutive months) with Octreotide Depot.

- In addition to documentation of progressive disease on or after chemotherapy,
patients in stratum 2 must have documented objective progression of disease while
receiving Octreotide Depot.

Exclusion criteria for both strata:

- Anticancer therapy within 3 weeks of enrollment.

- Patients with poorly differentiated neuroendocrine carcinoma

- Hepatic artery embolization within the last 6 months

- Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)

- Other concurrent malignancy

- Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses

Exclusion Criterion for Stratum 1 only:

• Received treatment with Octreotide Depot or any other long-acting somatostatin analogue
in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two
weeks prior to enrollment.

Other protocol-defined inclusion/exclusion criteria applied.