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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
0
0
A6181037
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Intervention/exposure
Study type
Expanded Access
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Description of intervention(s) / exposure
Treatment: Drugs - Sutent
Treatment: Drugs: Sutent
Sutent, 25, 37.5. or 50 mg daily
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* renal cell carcinoma that is not amendable to standard therapy with curative intent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* current treatment in another therapeutic clinical trial
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Study design
Purpose of the study
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
APPROVED_FOR_MARKETING
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2011
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Randwick
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Recruitment hospital [2]
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Pfizer Investigational Site - St Leonards
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Recruitment hospital [3]
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Pfizer Investigational Site - Westmead
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Recruitment hospital [4]
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Pfizer Investigational Site - South Brisbane
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Recruitment hospital [5]
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Pfizer Investigational Site - Elizabeth Vale
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Recruitment hospital [6]
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Pfizer Investigational Site - Woodville South
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Recruitment hospital [7]
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Pfizer Investigational Site - East Melbourne
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Recruitment hospital [8]
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Pfizer Investigational Site - Heidelburg
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Recruitment hospital [9]
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Pfizer Investigational Site - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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5011 - Woodville South
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Recruitment postcode(s) [7]
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3002 - East Melbourne
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Recruitment postcode(s) [8]
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3084 - Heidelburg
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Recruitment postcode(s) [9]
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6000 - Perth
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
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Commercial sector/industry
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Name
Pfizer
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00130897
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Trial related presentations / publications
Barrios CH, Herchenhorn D, Chacon M, Cabrera-Galeana P, Sajben P, Zhang K. Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma. Onco Targets Ther. 2016 Sep 23;9:5839-5845. doi: 10.2147/OTT.S109445. eCollection 2016. Lee SH, Bang YJ, Mainwaring P, Ng C, Chang JW, Kwong P, Li RK, Sriuranpong V, Toh CK, Yuan J, Pitman Lowenthal S, Chung HC. Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy. Asia Pac J Clin Oncol. 2014 Sep;10(3):237-45. doi: 10.1111/ajco.12163. Epub 2014 Feb 27. Gore ME, Hariharan S, Porta C, Bracarda S, Hawkins R, Bjarnason GA, Oudard S, Lee SH, Carteni G, Nieto A, Yuan J, Szczylik C. Sunitinib in metastatic renal cell carcinoma patients with brain metastases. Cancer. 2011 Feb 1;117(3):501-9. doi: 10.1002/cncr.25452. Epub 2010 Sep 22. Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schoffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009 Aug;10(8):757-63. doi: 10.1016/S1470-2045(09)70162-7. Epub 2009 Jul 15.
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Public notes
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT00130897
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