BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

Inclusion Criteria:

- Unresectable or metastatic, histologically confirmed low or intermediate grade
pancreatic neuroendocrine tumor with radiological evidence of disease progression
since last treatment

- Refractory disease to treatment with mTOR inhibitor

- Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic
Resonance Imaging (MRI)

- Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months
prior to study start and must continue on the stable dose while receiving study
treatment; SSA is not considered as a systemic treatment.

- WHO PS ≤ 1

- Adequate bone marrow function or organ function

Exclusion Criteria:

- Previous treatment with any PI3K or AKT inhibitor

- Discontinuation prior mTOR inhibitor therapy due to toxicity

- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoid and small cell carcinoma

- Radiotherapy, or major surgery within 4 weeks prior to study treatment start

- Hepatic artery embolization or cryoablation/ radiofrequency ablation of hepatic
metastasis within 2 months of study treatment start.

- More than 3 prior systemic treatment regimens (including cytotoxic chemotherapy,
targeted therapy, immunotherapy)

Other protocol defined inclusion/exclusion criteria may apply.