Clinical trial NCT00655252: 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
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Metastatic Renal Cell Cancer
Keywords: Expanded access
metastatic renal cell cancer
progression despite VEGF receptors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands oncology Group, PA
state: Arkansas
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center/Anschutz Pavillion
state: Colorado
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center - Orlando
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Cancer center
state: Indiana
city: Towson
country: United States
facility: The Cancer Institute, St. Joseph Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Kansas City
country: United States
facility: Heartland Hematology-Oncology Associates, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Washington University/Siteman Cancer Center
state: Missouri
city: Charlotte
country: United States
facility: Blumenthal Cancer Center/Carolinas Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cliveland Clinic Foundation
state: Ohio
city: Lawton
country: United States
facility: Cleo Craig Memorial Cancer & Research Clinic
state: Oklahoma
city: Greenville
country: United States
facility: Cancer centers of the Carolinas
state: South Carolina
city: Malvern
country: Australia
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Brussels
country: Belgium
facility: Novartis Investigative Site
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: QE ll Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridhe Health Corp - Oshawa
state: Ontario
city: Sault Ste Marie
country: Canada
facility: Sault Area Hospital - General Site
state: Ontario
city: Montreal
country: Canada
facility: Les Urologues Associes du CHUM
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
city: Brno
country: Czech Republic
facility: Novartis Investigative Site
city: Prague 2
country: Czech Republic
facility: Novartis Investigative Site
city: Prague
country: Czech Republic
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bautzen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt/Main
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Goslar
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Koln
country: Germany
facility: Novartis Investigative site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munster
country: Germany
facility: Novartis Investigative site
city: Nurnberg
country: Germany
facility: Novartis Investidative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Recklinghausen
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Alesund
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Geneva
country: Switzerland
facility: Novartis Investigative Site
city: St. Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: British Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Glasgow
country: United Kingdom
facility: CRUK
city: Hampshire
country: United Kingdom
facility: Southampton University Hospital NHS Trust,
city: Leicester
country: United Kingdom
facility: Oncology & Haematology Clinical Tirals Unit
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: The Christie Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle General Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Surrey
country: United Kingdom
facility: St Luke's Wing, Royal Surrey County Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bracarda S, Rottey S, Bahl A, Eichelberg C, Mellado B, Mangel L, Cattaneo A, Panneerselvam A, Grunwald V. REACT expanded-access program in patients with metastatic renal cell carcinoma: real-world data from a European subanalysis. Future Oncol. 2015;11(21):2893-903. doi: 10.2217/fon.15.241. Epub 2015 Sep 17.
citation: Grunwald V, Karakiewicz PI, Bavbek SE, Miller K, Machiels JP, Lee SH, Larkin J, Bono P, Rha SY, Castellano D, Blank CU, Knox JJ, Hawkins R, Anak O, Rosamilia M, Booth J, Pirotta N, Bodrogi I; REACT Study Group. An international expanded-access programme of everolimus: addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy. Eur J Cancer. 2012 Feb;48(3):324-32. doi: 10.1016/j.ejca.2011.06.054. Epub 2011 Jul 29.