Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

Inclusion criteria

• Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
• Adequate bone marrow, liver and renal function on everolimus treatment
• At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
• Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer.
• Age >18 years

Exclusion criteria

• Women who are pregnant or breast feeding.
• Documented intolerance or history of allergy to everolimus or Gemcitabine.
• History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
• Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
• Chronic treatment with systemic steroids or another immunosuppressive agent
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value < 50 % or prothrombine time more than 1,5 fold higher

Other protocol defined inclusion/exclusion criteria may apply