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
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
1 other identifier
expanded_access
N/A
12 countries
80
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedAugust 19, 2011
August 1, 2011
April 7, 2008
August 18, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
Highlands oncology Group, PA
Springdale, Arkansas, 72764, United States
University of Colorado Health Sciences Center/Anschutz Pavillion
Aurora, Colorado, 12801, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
MD Anderson Cancer Center - Orlando
Orlando, Florida, 32806, United States
Indiana University Cancer center
Indianapolis, Indiana, 46202, United States
The Cancer Institute, St. Joseph Medical Center
Towson, Maryland, 21209, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Heartland Hematology-Oncology Associates, Inc.
Kansas City, Missouri, 64118, United States
Washington University/Siteman Cancer Center
St Louis, Missouri, 63110, United States
Blumenthal Cancer Center/Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Cliveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Cleo Craig Memorial Cancer & Research Clinic
Lawton, Oklahoma, 73505, United States
Cancer centers of the Carolinas
Greenville, South Carolina, 29615, United States
Novartis Investigative Site
Malvern, Australia
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Graz, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Brussels, Belgium
Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
QE ll Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
Lakeridhe Health Corp - Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Sault Area Hospital - General Site
Sault Ste. Marie, Ontario, P6A 2C4, Canada
Les Urologues Associes du CHUM
Montreal, Quebec, H2X 1N8, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, S7N 4H4, Canada
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Brno, Czechia
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Prague, Czechia
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Augsburg, Germany
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Bautzen, Germany
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Berlin, Germany
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Bremen, Germany
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Chemnitz, Germany
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Cologne, Germany
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Dresden, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Frankfurt am Main, Germany
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Freiburg im Breisgau, Germany
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Fulda, Germany
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Goslar, Germany
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Hamburg, Germany
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Hanover, Germany
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Jena, Germany
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Leipzig, Germany
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Magdeburg, Germany
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Mainz, Germany
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Mannheim, Germany
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München, Germany
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Münster, Germany
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Nuremberg, Germany
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Offenburg, Germany
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Oldenburg, Germany
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Recklinghausen, Germany
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Rostock, Germany
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Tübingen, Germany
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Wuppertal, Germany
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Budapest, Hungary
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Beirut, Lebanon
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Ålesund, Norway
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Oslo, Norway
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Geneva, Switzerland
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Sankt Gallen, Switzerland
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
British Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
CRUK
Glasgow, G61 1BD, United Kingdom
Southampton University Hospital NHS Trust,
Hampshire, SO16 6YD, United Kingdom
Oncology & Haematology Clinical Tirals Unit
Leicester, LE1 5WW, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
The Christie Hospital
Manchester, M20 9BX, United Kingdom
Newcastle General Hospital
Newcastle, NE4 6BE, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
St Luke's Wing, Royal Surrey County Hospital
Surrey, GU2 7XX, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Related Publications (2)
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.
PMID: 26376939DERIVEDGrunwald 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.
PMID: 21803569DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals