Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

August 18, 2011 updated by: Novartis Pharmaceuticals

An Open-Label, Multi-Center, Expanded Access Study of RAD001 in Patients With Metastatic Carcinoma of the Kidney Who Are Intolerant of or Have Progressed Despite Any AvailableVascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy

This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Malvern, Australia
        • Novartis Investigative Site
  • Austria
      • Graz, Austria
        • Novartis Investigative Site
      • Linz, Austria
        • Novartis Investigative Site
      • Salzburg, Austria
        • Novartis Investigative Site
      • Vienna, Austria
        • Novartis Investigative Site
  • Belgium
      • Brussels, Belgium
        • Novartis Investigative Site
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QE ll Health Sciences Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridhe Health Corp - Oshawa
      • Sault Ste Marie, Ontario, Canada, P6A 2C4
        • Sault Area Hospital - General Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 1N8
        • Les Urologues Associes du CHUM
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Center
  • Czech Republic
      • Brno, Czech Republic
        • Novartis Investigative Site
      • Prague, Czech Republic
        • Novartis Investigative Site
      • Prague 2, Czech Republic
        • Novartis Investigative Site
  • Germany
      • Augsburg, Germany
        • Novartis Investigative Site
      • Bautzen, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Bremen, Germany
        • Novartis Investigative Site
      • Chemnitz, Germany
        • Novartis Investigative Site
      • Dresden, Germany
        • Novartis Investigative Site
      • Erlangen, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Frankfurt/Main, Germany
        • Novartis Investigative Site
      • Freiburg, Germany
        • Novartis Investigative Site
      • Fulda, Germany
        • Novartis Investigative Site
      • Goslar, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Hannover, Germany
        • Novartis Investigative Site
      • Jena, Germany
        • Novartis Investigative Site
      • Koln, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Magdeburg, Germany
        • Novartis Investigative Site
      • Mainz, Germany
        • Novartis Investigative Site
      • Mannheim, Germany
        • Novartis Investigative Site
      • Munchen, Germany
        • Novartis Investigative Site
      • Munster, Germany
        • Novartis Investigative Site
      • Nurnberg, Germany
        • Novartis Investidative Site
      • Offenburg, Germany
        • Novartis Investigative Site
      • Oldenburg, Germany
        • Novartis Investigative Site
      • Recklinghausen, Germany
        • Novartis Investigative Site
      • Rostock, Germany
        • Novartis Investigative Site
      • Tubingen, Germany
        • Novartis Investigative Site
      • Wuppertal, Germany
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon
        • Novartis Investigative Site
  • Norway
      • Alesund, Norway
        • Novartis Investigative Site
      • Oslo, Norway
        • Novartis Investigative Site
  • Switzerland
      • Geneva, Switzerland
        • Novartis Investigative Site
      • St. Gallen, Switzerland
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey
        • Novartis Investigative Site
      • Istanbul, Turkey
        • Novartis Investigative Site
      • Izmir, Turkey
        • Novartis Investigative Site
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS2 8ED
        • British Haematology and Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Glasgow, United Kingdom, G61 1BD
        • CRUK
      • Hampshire, United Kingdom, SO16 6YD
        • Southampton University Hospital NHS Trust,
      • Leicester, United Kingdom, LE1 5WW
        • Oncology & Haematology Clinical Tirals Unit
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' NHS Foundation Trust
      • Manchester, United Kingdom, M20 9BX
        • The Christie Hospital
      • Newcastle, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
      • Surrey, United Kingdom, GU2 7XX
        • St Luke's Wing, Royal Surrey County Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group, PA
    • Colorado
      • Aurora, Colorado, United States, 12801
        • University of Colorado Health Sciences Center/Anschutz Pavillion
    • Florida
      • Ocoee, Florida, United States, 34761
        • Cancer Centers of Florida, P.A.
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center - Orlando
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Maryland
      • Towson, Maryland, United States, 21209
        • The Cancer Institute, St. Joseph Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • Kansas City, Missouri, United States, 64118
        • Heartland Hematology-Oncology Associates, Inc.
      • St. Louis, Missouri, United States, 63110
        • Washington University/Siteman Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Blumenthal Cancer Center/Carolinas Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • Cliveland Clinic Foundation
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cleo Craig Memorial Cancer & Research Clinic
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion criteria:

  • ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib
  • Adequate bone marrow function, liver function, renal function
  • Adequate birth control

Exclusion criteria:

  • Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK
  • Topical or inhaled steroids OK)
  • Active bleeding
  • Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 7, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001L2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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