Advanced or Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
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
| Verified date | November 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A dose finding study in locally advanced and/or metastatic pancreatic cancer patients
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis Investigative Site | Halle | |
| Germany | Novartis Investigative Site | Merseburg | |
| Germany | Novartis Investigative Site | München | |
| Germany | Novartis Investigative Site | Oberstaufen | |
| Germany | Novartis Investigative Site | Ulm |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine | 8 weeks | ||
| Secondary | Safety & tolerability, pharmacokinetic assessments of Everolimus and Gemcitabine combination therapy in these patient populations. Phase II objective response rates (ORR), duration of response, progression-free survival (PFS), overall survival (OS) | 36 weeks |