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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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