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Metastatic Renal Cell CancerNCT00655252

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

A study testing Everolimus in people with Metastatic Renal Cell Cancer, run by Novartis Pharmaceuticals at 84 sites in 13 countries.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Cancer
What is being tested?
Everolimus
How many people
Not given
Where
84 sitesin 13 countries
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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

Trial locations and contacts

84 sites in 13 countries.

84 sites in 13 countries

Germany30 sites

  • Novartis Investigative Site

    Augsburg

  • Novartis Investigative Site

    Bautzen

  • Novartis Investigative Site

    Berlin

  • Novartis Investigative Site

    Bremen

  • Novartis Investigative Site

    Chemnitz

  • Novartis Investigative site

    Cologne

  • Novartis Investigative Site

    Dresden

  • Novartis Investigative Site

    Erlangen

  • Novartis Investigative Site

    Essen

  • Novartis Investigative Site

    Frankfurt

  • Novartis Investigative Site

    Frankfurt am Main

  • Novartis Investigative Site

    Freiburg im Breisgau

  • Novartis Investigative Site

    Fulda

  • Novartis Investigative Site

    Goslar

  • Novartis Investigative Site

    Hamburg

  • Novartis Investigative Site

    Hanover

  • Novartis Investigative Site

    Jena

  • Novartis Investigative Site

    Leipzig

  • Novartis Investigative Site

    Magdeburg

  • Novartis Investigative Site

    Mainz

  • Novartis Investigative Site

    Mannheim

  • Novartis Investigative Site

    München

  • Novartis Investigative site

    Münster

  • Novartis Investidative Site

    Nuremberg

  • Novartis Investigative Site

    Offenburg

  • Novartis Investigative Site

    Oldenburg

  • Novartis Investigative Site

    Recklinghausen

  • Novartis Investigative Site

    Rostock

  • Novartis Investigative Site

    Tübingen

  • Novartis Investigative Site

    Wuppertal

Other trials in Germany

United States15 sites

  • University of Colorado Health Sciences Center/Anschutz Pavillion

    Aurora, Colorado, 12801

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Blumenthal Cancer Center/Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Cliveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Cancer centers of the Carolinas

    Greenville, South Carolina, 29615

  • Indiana University Cancer center

    Indianapolis, Indiana, 46202

  • Heartland Hematology-Oncology Associates, Inc.

    Kansas City, Missouri, 64118

  • Cleo Craig Memorial Cancer & Research Clinic

    Lawton, Oklahoma, 73505

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • MD Anderson Cancer Center - Orlando

    Orlando, Florida, 32806

  • Highlands oncology Group, PA

    Springdale, Arkansas, 72764

  • Washington University/Siteman Cancer Center

    St Louis, Missouri, 63110

  • The Cancer Institute, St. Joseph Medical Center

    Towson, Maryland, 21209

Other trials in United States

United Kingdom14 sites

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • British Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • CRUK

    Glasgow, G61 1BD

  • Southampton University Hospital NHS Trust,

    Hampshire, SO16 6YD

  • Oncology & Haematology Clinical Tirals Unit

    Leicester, LE1 5WW

  • Royal Free Hospital

    London, NW3 2QG

  • Guy's and St. Thomas' NHS Foundation Trust

    London, SE1 9RT

  • Royal Marsden Hospital

    London, SW3 6JJ

  • The Christie Hospital

    Manchester, M20 9BX

  • Newcastle General Hospital

    Newcastle, NE4 6BE

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • St Luke's Wing, Royal Surrey County Hospital

    Surrey, GU2 7XX

  • Singleton Hospital

    Swansea, SA2 8QA

Other trials in United Kingdom

Canada8 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • QE ll Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Les Urologues Associes du CHUM

    Montreal, Quebec, H2X 1N8

  • Lakeridhe Health Corp - Oshawa

    Oshawa, Ontario, L1G 2B9

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan, S7N 4H4

  • Sault Area Hospital - General Site

    Sault Ste. Marie, Ontario, P6A 2C4

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Austria4 sites

  • Novartis Investigative Site

    Graz

  • Novartis Investigative Site

    Linz

  • Novartis Investigative Site

    Salzburg

  • Novartis Investigative Site

    Vienna

Other trials in Austria

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara

  • Novartis Investigative Site

    Istanbul

  • Novartis Investigative Site

    Izmir

Other trials in Turkey (Türkiye)

Czechia2 sites

  • Novartis Investigative Site

    Brno

  • Novartis Investigative Site

    Prague

Other trials in Czechia

Norway2 sites

  • Novartis Investigative Site

    Ålesund

  • Novartis Investigative Site

    Oslo

Other trials in Norway

Switzerland2 sites

  • Novartis Investigative Site

    Geneva

  • Novartis Investigative Site

    Sankt Gallen

Other trials in Switzerland

Australia1 site

  • Novartis Investigative Site

    Malvern

Other trials in Australia

Belgium1 site

  • Novartis Investigative Site

    Brussels

Other trials in Belgium

Hungary1 site

  • Novartis Investigative Site

    Budapest

Other trials in Hungary

Lebanon1 site

  • Novartis Investigative Site

    Beirut

Other trials in Lebanon

About this study

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

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

Being tested
Everolimus
Keywords
Expanded access, metastatic renal cell cancer, progression despite VEGF receptors
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00655252
Sponsor's protocol ID
CRAD001L2401
Status last verified
Aug 2011
First submitted
7 Apr 2008
Last updated
19 Aug 2011
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Everolimus in people with Metastatic Renal Cell Cancer, run by Novartis Pharmaceuticals at 84 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Germany, United States, United Kingdom, Canada, Austria and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655252, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.

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