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 currently available for this treatment.

Verified by Novartis, August 2009

First Received: April 7, 2008 Last Updated: August 3, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00655252

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
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:

MedlinePlus related topics: Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655252

Contacts

Contact: Novartis US

800 340 6843

Show 84 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Expanded access for renal cell cancer This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001L2401
Study First Received:	April 7, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00655252 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

Expanded access
metastatic renal cell cancer
progression despite VEGF receptors

Study placed in the following topic categories:

Everolimus
Urinary Tract Neoplasm
Kidney Cancer
Immunologic Factors
Disease Progression
Tyrosine
Urogenital Neoplasms
Endothelial Growth Factors
Urologic Neoplasms
Immunosuppressive Agents

Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Mitogens
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Everolimus
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Urogenital Neoplasms
Endothelial Growth Factors
Urologic Neoplasms
Immunosuppressive Agents

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Mitogens
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 09, 2009