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

NCT ID: NCT00655252

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

Detailed Description

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Conditions

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Metastatic Renal Cell Cancer

Interventions

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Everolimus

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Highlands oncology Group, PA

Springdale, Arkansas, United States

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University of Colorado Health Sciences Center/Anschutz Pavillion

Aurora, Colorado, United States

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Cancer Centers of Florida, P.A.

Ocoee, Florida, United States

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MD Anderson Cancer Center - Orlando

Orlando, Florida, United States

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Indiana University Cancer center

Indianapolis, Indiana, United States

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The Cancer Institute, St. Joseph Medical Center

Towson, Maryland, United States

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Henry Ford Health System

Detroit, Michigan, United States

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Missouri Cancer Associates

Columbia, Missouri, United States

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Heartland Hematology-Oncology Associates, Inc.

Kansas City, Missouri, United States

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Washington University/Siteman Cancer Center

St Louis, Missouri, United States

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Blumenthal Cancer Center/Carolinas Medical Center

Charlotte, North Carolina, United States

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Gabrail Cancer Center

Canton, Ohio, United States

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Cliveland Clinic Foundation

Cleveland, Ohio, United States

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Cleo Craig Memorial Cancer & Research Clinic

Lawton, Oklahoma, United States

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Cancer centers of the Carolinas

Greenville, South Carolina, United States

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Novartis Investigative Site

Malvern, , Australia

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Novartis Investigative Site

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

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Moncton Hospital

Moncton, New Brunswick, Canada

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QE ll Health Sciences Centre

Halifax, Nova Scotia, Canada

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Royal Victoria Hospital

Barrie, Ontario, Canada

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Lakeridhe Health Corp - Oshawa

Oshawa, Ontario, Canada

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Sault Area Hospital - General Site

Sault Ste. Marie, Ontario, Canada

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Les Urologues Associes du CHUM

Montreal, Quebec, Canada

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

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Saskatoon Cancer Center

Saskatoon, Saskatchewan, Canada

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Novartis Investigative Site

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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Novartis Investigative Site

Izmir, , Turkey (Türkiye)

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Royal Bournemouth Hospital

Bournemouth, , United Kingdom

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British Haematology and Oncology Centre

Bristol, , United Kingdom

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Addenbrookes Hospital

Cambridge, , United Kingdom

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CRUK

Glasgow, , United Kingdom

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Southampton University Hospital NHS Trust,

Hampshire, , United Kingdom

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Oncology & Haematology Clinical Tirals Unit

Leicester, , United Kingdom

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Royal Free Hospital

London, , United Kingdom

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Guy's and St. Thomas' NHS Foundation Trust

London, , United Kingdom

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Royal Marsden Hospital

London, , United Kingdom

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The Christie Hospital

Manchester, , United Kingdom

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Newcastle General Hospital

Newcastle, , United Kingdom

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Mount Vernon Cancer Centre

Northwood, , United Kingdom

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St Luke's Wing, Royal Surrey County Hospital

Surrey, , United Kingdom

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Singleton Hospital

Swansea, , United Kingdom

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Countries

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United States Australia Austria Belgium Canada Czechia Germany Hungary Lebanon Norway Switzerland Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26376939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21803569 (View on PubMed)

Related Links

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http://www.novartisclinicaltrials.com//webapp/etrials/DiseaseID97/Kidney-Cancer(renal-cell-cancer)-clinicaltrials.go

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

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CRAD001L2401

Identifier Type: -

Identifier Source: org_study_id

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