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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

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ClinicalTrials.gov Identifier: NCT00655252
Expanded Access Status : No longer available
First Posted : April 9, 2008
Last Update Posted : August 19, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment
Metastatic Renal Cell Cancer Drug: Everolimus

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Study Type : 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

Information from the National Library of Medicine

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

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

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

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00655252    
Other Study ID Numbers: CRAD001L2401
First Posted: April 9, 2008    Key Record Dates
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:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs