Combination of Antiangiogenic Therapy Using the mTOR-inhibitor RAD001 and Low Dose Chemotherapy for Locally Advanced and/or Metastatic Pancreatic Cancer - a Dose Finding Study
1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma
(head, corpus, tail) with or without distant metastases
2. Adequate bone marrow, liver and renal function on everolimus treatment
3. At least one measurable lesion according to RECIST criteria that has not been
4. 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.
5. Age >18 years
1. Women who are pregnant or breast feeding.
2. Documented intolerance or history of allergy to everolimus or Gemcitabine.
3. History of another malignancy within 5 years prior to study entry, except curatively
treated non-melanotic skin cancer or in-situ cervical cancer
4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal
5. Chronic treatment with systemic steroids or another immunosuppressive agent
6. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of everolimus
7. 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
Other protocol defined inclusion/exclusion criteria may apply