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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560963
First Posted: November 20, 2007
Last Update Posted: November 15, 2012
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
A dose finding study in locally advanced and/or metastatic pancreatic cancer patients

Condition Intervention Phase
Advanced or Metastatic Pancreatic Adenocarcinoma Drug: everolimus Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 36 weeks ]

Enrollment: 21
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 RAD001 Drug: everolimus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560963


Locations
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, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00560963     History of Changes
Other Study ID Numbers: CRAD001C2491
First Submitted: November 19, 2007
First Posted: November 20, 2007
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced or metastatic pancreas carcinoma
gemcitabine
everolimus

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Everolimus
Sirolimus
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents


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