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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A dose finding study in locally advanced and/or metastatic pancreatic cancer patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Gemcitabine; Sirolimus

Criteria

Inclusion criteria:

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 previously irradiated.

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

Exclusion criteria:

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 involvement

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 fold higher

Other protocol defined inclusion/exclusion criteria may apply