Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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