A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)

Inclusion Criteria

Inclusion criteria:

1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET

2. Measurable disease by radiologic assessment

3. Adequate blood work

4. Performance Status 0-2 : Ability to be out of bed most of the time

5. Adult male or female patients ≥ 18 years of age

6. Women of childbearing potential must have a negative serum pregnancy test

7. Written informed consent from patients must be obtained in accordance to local
guidelines

Exclusion criteria:

1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma,
high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small
cell carcinoma) cancer are not eligible

2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting
this trial

3. Hepatic artery procedure called embolization within the last 6 months (1 month if
there are other sites of measurable disease), or cryoablation/ radiofrequency
ablation of hepatic metastasis within 2 months of enrollment

4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus,
temsirolimus, everolimus).

5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled
medical conditions such as:

6. Patients receiving chronic treatment with corticosteroids or another
immunosuppressive agent

7. Patients with a known history of HIV seropositivity

8. No other prior or concurrent cancer at the time enrolling to this trial

Other protocol defined inclusion/ exclusion criteria applied