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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced or Metastatic Pancreatic Adenocarcinoma

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CRAD001C2491

NCT ID:

NCT00560963

Start Date:

October 2007

Completion Date:

January 2011

Related Keywords:

  • Advanced or Metastatic Pancreatic Adenocarcinoma
  • Advanced or metastatic pancreas carcinoma
  • gemcitabine
  • everolimus
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

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