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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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655252
First Posted: April 9, 2008
Last Update Posted: August 19, 2011
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
This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

Condition Intervention
Metastatic Renal Cell Cancer Drug: Everolimus

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

  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): NCT00655252


  Show 85 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00655252     History of Changes
Other Study ID Numbers: CRAD001L2401
First Submitted: April 7, 2008
First Posted: April 9, 2008
Last Update Posted: August 19, 2011
Last Verified: August 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Expanded access
metastatic renal cell cancer
progression despite VEGF receptors

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Mitogens
Endothelial Growth Factors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances