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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00130897




Registration number
NCT00130897
Ethics application status
Date submitted
14/08/2005
Date registered
16/08/2005
Date last updated
9/03/2012

Titles & IDs
Public title
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Scientific title
A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
Secondary ID [1] 0 0
A6181037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Sutent

Treatment: Drugs: Sutent
Sutent, 25, 37.5. or 50 mg daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- renal cell carcinoma that is not amendable to standard therapy with curative intent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- current treatment in another therapeutic clinical trial

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
Approved for marketing
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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Elizabeth Vale
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [7] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Heidelburg
Recruitment hospital [9] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Heidelburg
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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United States of America
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Connecticut
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Florida
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State/province [6] 0 0
Georgia
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State/province [7] 0 0
Illinois
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United States of America
State/province [8] 0 0
Indiana
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Iowa
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New York
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Wilrijk
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Sarajevo
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MG
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RJ
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RS
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Sofia
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Rennes
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France
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Tours
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Hannover
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Jena
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Germany
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Kassel
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Muenchen
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Germany
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Nuernberg
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Germany
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Rostock
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Germany
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Ulm
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Patras
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Greece
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Hong Hong
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Hungary
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Mumbai
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Rajasthan
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Israel
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Tel Hashomer
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Italy
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Biel
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CH-4058 Basel
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Switzerland
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Switzerland
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Chur
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Se1 9rt
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West Yorkshire
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Belfast
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Birmingham
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Bristol
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Cottingham
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Edinburgh
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Guildford
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Manchester
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Northwood
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Nottingham
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
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Swansea
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Venezuela
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Distrito Capital
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Venezuela
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Estado Miranda

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this protocol is to provide access to SU011248 treatment for
patients with metastatic RCC who are ineligible for participation in ongoing SU011248
clinical studies and have the potential to derive clinical benefit from treatment with
SU011248 based on the judgment of the investigator.
Trial website
https://clinicaltrials.gov/show/NCT00130897
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/show/NCT00130897