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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced or Metastatic Pancreatic Adenocarcinoma

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560963

CRAD001C2491

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

1 RAD001

Experimental group

Treatment:

Drug: everolimus