CClinicalTrials.gg
No longer availableNCT00655252Updated Aug 19, 2011

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 expanded access record providing Everolimus in Metastatic Renal Cell Cancer, sponsored by Novartis Pharmaceuticals. No longer available at 85 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-19.

Sponsored by Novartis Pharmaceuticals · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Renal Cell Cancer

Keywords

  • Expanded access
  • metastatic renal cell cancer
  • progression despite VEGF receptors
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

05

Access details

Study type
Expanded access

Available treatment

  • DrugEverolimus
06

Where to request access

85 sites
  • 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
  • Novartis Investigative Site
    Graz, Austria
  • Novartis Investigative Site
    Linz, Austria
  • Novartis Investigative Site
    Salzburg, Austria
  • Novartis Investigative Site
    Vienna, Austria
  • Novartis Investigative Site
    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
  • Novartis Investigative Site
    Brno, Czech Republic
  • Novartis Investigative Site
    Prague 2, Czech Republic
  • Novartis Investigative Site
    Prague, Czech Republic
  • 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/Main, Germany
  • Novartis Investigative Site
    Frankfurt, 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, Germany
  • Novartis Investigative Site
    Budapest, Hungary
  • Novartis Investigative Site
    Beirut, Lebanon
  • Novartis Investigative Site
    Alesund, Norway
  • Novartis Investigative Site
    Oslo, Norway
  • Novartis Investigative Site
    Geneva, Switzerland
  • Novartis Investigative Site
    St. Gallen, Switzerland
  • Novartis Investigative Site
    Ankara, Turkey
  • Novartis Investigative Site
    Istanbul, Turkey
  • Novartis Investigative Site
    Izmir, Turkey
  • 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
07

References and documents

Publications

  • 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. PubMed 26376939 ↗
  • 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. PubMed 21803569 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00655252
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 9, 2008
Last update
Aug 19, 2011

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Requesting access

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