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

Metastatic Renal Cell Cancer Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00655252
• Other study ID #: CRAD001L2401
• Status: No longer available
• Phase: N/A
• First received: April 7, 2008
• Last updated: August 18, 2011

Study information

• Verified date: August 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Cancer

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Malvern
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Brussels
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	QE ll Health Sciences Centre	Halifax	Nova Scotia
Canada	Moncton Hospital	Moncton	New Brunswick
Canada	Les Urologues Associes du CHUM	Montreal	Quebec
Canada	Lakeridhe Health Corp - Oshawa	Oshawa	Ontario
Canada	Saskatoon Cancer Center	Saskatoon	Saskatchewan
Canada	Sault Area Hospital - General Site	Sault Ste Marie	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Czech Republic	Novartis Investigative Site	Brno
Czech Republic	Novartis Investigative Site	Prague
Czech Republic	Novartis Investigative Site	Prague 2
Germany	Novartis Investigative Site	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 Investidative Site	Nurnberg
Germany	Novartis Investigative 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
Hungary	Novartis Investigative Site	Budapest
Lebanon	Novartis Investigative Site	Beirut
Norway	Novartis Investigative Site	Alesund
Norway	Novartis Investigative Site	Oslo
Switzerland	Novartis Investigative Site	Geneva
Switzerland	Novartis Investigative Site	St. Gallen
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	British Haematology and Oncology Centre	Bristol
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	CRUK	Glasgow
United Kingdom	Southampton University Hospital NHS Trust,	Hampshire
United Kingdom	Oncology & Haematology Clinical Tirals Unit	Leicester
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	The Christie Hospital	Manchester
United Kingdom	Newcastle General Hospital	Newcastle
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	St Luke's Wing, Royal Surrey County Hospital	Surrey
United Kingdom	Singleton Hospital	Swansea
United States	University of Colorado Health Sciences Center/Anschutz Pavillion	Aurora	Colorado
United States	Gabrail Cancer Center	Canton	Ohio
United States	Blumenthal Cancer Center/Carolinas Medical Center	Charlotte	North Carolina
United States	Cliveland Clinic Foundation	Cleveland	Ohio
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Henry Ford Health System	Detroit	Michigan
United States	Cancer centers of the Carolinas	Greenville	South Carolina
United States	Indiana University Cancer center	Indianapolis	Indiana
United States	Heartland Hematology-Oncology Associates, Inc.	Kansas City	Missouri
United States	Cleo Craig Memorial Cancer & Research Clinic	Lawton	Oklahoma
United States	Cancer Centers of Florida, P.A.	Ocoee	Florida
United States	MD Anderson Cancer Center - Orlando	Orlando	Florida
United States	Highlands oncology Group, PA	Springdale	Arkansas
United States	Washington University/Siteman Cancer Center	St. Louis	Missouri
United States	The Cancer Institute, St. Joseph Medical Center	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Germany,  Hungary,  Lebanon,  Norway,  Switzerland,  Turkey,  United Kingdom,