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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00655252




Registration number
NCT00655252
Ethics application status
Date submitted
7/04/2008
Date registered
9/04/2008
Date last updated
19/08/2011

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
CRAD001L2401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
NO_LONGER_AVAILABLE
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Malvern
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment outside Australia
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United States of America
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Arkansas
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United States of America
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Colorado
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Florida
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Indiana
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Maryland
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Michigan
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Missouri
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North Carolina
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Ohio
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Oklahoma
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United States of America
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South Carolina
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Austria
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Graz
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Brussels
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Czech Republic
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Brno
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Czech Republic
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Prague 2
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Czech Republic
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Prague
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Germany
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Augsburg
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Bautzen
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Berlin
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Bremen
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Chemnitz
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Dresden
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt/Main
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Fulda
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Germany
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Goslar
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Germany
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Hamburg
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Germany
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Hannover
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Jena
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Germany
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Koln
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Leipzig
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Munchen
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Munster
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Germany
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Nurnberg
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Germany
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Offenburg
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Germany
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Oldenburg
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Germany
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Recklinghausen
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Germany
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Rostock
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Germany
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Tubingen
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Germany
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Wuppertal
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Hungary
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Budapest
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Lebanon
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Beirut
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Norway
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Alesund
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Norway
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Oslo
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Switzerland
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Geneva
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Switzerland
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St. Gallen
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Bournemouth
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Hampshire
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle
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United Kingdom
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Northwood
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United Kingdom
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Surrey
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United Kingdom
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00655252
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00655252