Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Sex
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
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
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
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Austria
State/province [30] 0 0
Innsbruck
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Bruxelles
Country [33] 0 0
Belgium
State/province [33] 0 0
Gent
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Liege
Country [36] 0 0
Belgium
State/province [36] 0 0
Wilrijk
Country [37] 0 0
Bosnia and Herzegovina
State/province [37] 0 0
Sarajevo
Country [38] 0 0
Brazil
State/province [38] 0 0
BA
Country [39] 0 0
Brazil
State/province [39] 0 0
MG
Country [40] 0 0
Brazil
State/province [40] 0 0
Rio Grande do Sul
Country [41] 0 0
Brazil
State/province [41] 0 0
RJ
Country [42] 0 0
Brazil
State/province [42] 0 0
RS
Country [43] 0 0
Brazil
State/province [43] 0 0
SP
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Sofia
Country [45] 0 0
Canada
State/province [45] 0 0
Alberta
Country [46] 0 0
Canada
State/province [46] 0 0
British Columbia
Country [47] 0 0
Canada
State/province [47] 0 0
Manitoba
Country [48] 0 0
Canada
State/province [48] 0 0
Newfoundland and Labrador
Country [49] 0 0
Canada
State/province [49] 0 0
Nova Scotia
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Chile
State/province [52] 0 0
RM
Country [53] 0 0
Colombia
State/province [53] 0 0
Cundinamarca
Country [54] 0 0
Colombia
State/province [54] 0 0
Cali
Country [55] 0 0
Croatia
State/province [55] 0 0
Rijeka
Country [56] 0 0
Croatia
State/province [56] 0 0
Split
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Brno
Country [58] 0 0
Czech Republic
State/province [58] 0 0
Hradec Kralove
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Praha 5
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Praha 8
Country [61] 0 0
Ecuador
State/province [61] 0 0
Guayas
Country [62] 0 0
Ecuador
State/province [62] 0 0
Pichincha
Country [63] 0 0
Egypt
State/province [63] 0 0
Cairo
Country [64] 0 0
Egypt
State/province [64] 0 0
Giza
Country [65] 0 0
Finland
State/province [65] 0 0
Turku
Country [66] 0 0
France
State/province [66] 0 0
Cedex 08
Country [67] 0 0
France
State/province [67] 0 0
Cedex
Country [68] 0 0
France
State/province [68] 0 0
Bordeaux
Country [69] 0 0
France
State/province [69] 0 0
Clermont Ferand
Country [70] 0 0
France
State/province [70] 0 0
Marseille Cedex 9
Country [71] 0 0
France
State/province [71] 0 0
Marseille
Country [72] 0 0
France
State/province [72] 0 0
Montpellier
Country [73] 0 0
France
State/province [73] 0 0
Paris Cedex 13
Country [74] 0 0
France
State/province [74] 0 0
Paris
Country [75] 0 0
France
State/province [75] 0 0
Reims
Country [76] 0 0
France
State/province [76] 0 0
Rennes
Country [77] 0 0
France
State/province [77] 0 0
Tours
Country [78] 0 0
France
State/province [78] 0 0
Vandoeuvre les Nancy
Country [79] 0 0
Germany
State/province [79] 0 0
Aachen
Country [80] 0 0
Germany
State/province [80] 0 0
Berlin
Country [81] 0 0
Germany
State/province [81] 0 0
Dresden
Country [82] 0 0
Germany
State/province [82] 0 0
Essen
Country [83] 0 0
Germany
State/province [83] 0 0
Frankfurt
Country [84] 0 0
Germany
State/province [84] 0 0
Freiburg
Country [85] 0 0
Germany
State/province [85] 0 0
Hamburg
Country [86] 0 0
Germany
State/province [86] 0 0
Hannover
Country [87] 0 0
Germany
State/province [87] 0 0
Homburg/Saar
Country [88] 0 0
Germany
State/province [88] 0 0
Jena
Country [89] 0 0
Germany
State/province [89] 0 0
Kassel
Country [90] 0 0
Germany
State/province [90] 0 0
Muenchen
Country [91] 0 0
Germany
State/province [91] 0 0
Nuernberg
Country [92] 0 0
Germany
State/province [92] 0 0
Rostock
Country [93] 0 0
Germany
State/province [93] 0 0
Ulm
Country [94] 0 0
Greece
State/province [94] 0 0
Attiki
Country [95] 0 0
Greece
State/province [95] 0 0
Athens
Country [96] 0 0
Greece
State/province [96] 0 0
Patras
Country [97] 0 0
Greece
State/province [97] 0 0
Thessaloniki
Country [98] 0 0
Hong Kong
State/province [98] 0 0
Hong Hong
Country [99] 0 0
Hungary
State/province [99] 0 0
Budapest
Country [100] 0 0
India
State/province [100] 0 0
Delhi
Country [101] 0 0
India
State/province [101] 0 0
Maharashtra
Country [102] 0 0
India
State/province [102] 0 0
Mumbai
Country [103] 0 0
India
State/province [103] 0 0
Rajasthan
Country [104] 0 0
India
State/province [104] 0 0
New Delhi
Country [105] 0 0
Ireland
State/province [105] 0 0
Dublin 24
Country [106] 0 0
Ireland
State/province [106] 0 0
Dublin
Country [107] 0 0
Israel
State/province [107] 0 0
Jerusalem
Country [108] 0 0
Israel
State/province [108] 0 0
Tel Hashomer
Country [109] 0 0
Italy
State/province [109] 0 0
Bergamo
Country [110] 0 0
Italy
State/province [110] 0 0
Brescia
Country [111] 0 0
Italy
State/province [111] 0 0
Cattolica (RN)
Country [112] 0 0
Italy
State/province [112] 0 0
Cuneo
Country [113] 0 0
Italy
State/province [113] 0 0
Legnago, VR
Country [114] 0 0
Italy
State/province [114] 0 0
Modena
Country [115] 0 0
Italy
State/province [115] 0 0
Napoli
Country [116] 0 0
Italy
State/province [116] 0 0
Padova
Country [117] 0 0
Italy
State/province [117] 0 0
Parma
Country [118] 0 0
Italy
State/province [118] 0 0
Pavia
Country [119] 0 0
Italy
State/province [119] 0 0
Perugia
Country [120] 0 0
Italy
State/province [120] 0 0
Pordenone
Country [121] 0 0
Italy
State/province [121] 0 0
Rimini
Country [122] 0 0
Italy
State/province [122] 0 0
Roma
Country [123] 0 0
Italy
State/province [123] 0 0
Torino
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Seoul
Country [125] 0 0
Lebanon
State/province [125] 0 0
Beirut
Country [126] 0 0
Malaysia
State/province [126] 0 0
Selangor
Country [127] 0 0
Malaysia
State/province [127] 0 0
Kuala Lumpur
Country [128] 0 0
Mexico
State/province [128] 0 0
DF
Country [129] 0 0
Mexico
State/province [129] 0 0
Estado de Mexico
Country [130] 0 0
Mexico
State/province [130] 0 0
Jalisco
Country [131] 0 0
Mexico
State/province [131] 0 0
Yucatan
Country [132] 0 0
Mexico
State/province [132] 0 0
Chihuahua
Country [133] 0 0
Mexico
State/province [133] 0 0
Puebla
Country [134] 0 0
Netherlands
State/province [134] 0 0
GR
Country [135] 0 0
Netherlands
State/province [135] 0 0
NH
Country [136] 0 0
Netherlands
State/province [136] 0 0
Amsterdam
Country [137] 0 0
Netherlands
State/province [137] 0 0
Rotterdam
Country [138] 0 0
Norway
State/province [138] 0 0
Oslo
Country [139] 0 0
Panama
State/province [139] 0 0
Ciudad de Panama
Country [140] 0 0
Panama
State/province [140] 0 0
Panama
Country [141] 0 0
Peru
State/province [141] 0 0
Lima
Country [142] 0 0
Philippines
State/province [142] 0 0
Quezon City
Country [143] 0 0
Poland
State/province [143] 0 0
Gdansk
Country [144] 0 0
Poland
State/province [144] 0 0
Lodz
Country [145] 0 0
Poland
State/province [145] 0 0
Poznan
Country [146] 0 0
Poland
State/province [146] 0 0
Warszawa
Country [147] 0 0
Poland
State/province [147] 0 0
Wroclaw
Country [148] 0 0
Portugal
State/province [148] 0 0
Lisboa
Country [149] 0 0
Portugal
State/province [149] 0 0
Porto
Country [150] 0 0
Romania
State/province [150] 0 0
Bucuresti
Country [151] 0 0
Romania
State/province [151] 0 0
Cluj-Napoca
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Kaluga region
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Chelyabinsk
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Moscow
Country [155] 0 0
Serbia
State/province [155] 0 0
Belgrade
Country [156] 0 0
Singapore
State/province [156] 0 0
Singapore
Country [157] 0 0
Slovakia
State/province [157] 0 0
Bratislava
Country [158] 0 0
Slovakia
State/province [158] 0 0
Zilina
Country [159] 0 0
Slovenia
State/province [159] 0 0
Ljubljana
Country [160] 0 0
Spain
State/province [160] 0 0
Asturias
Country [161] 0 0
Spain
State/province [161] 0 0
Barcelona
Country [162] 0 0
Spain
State/province [162] 0 0
Navarra
Country [163] 0 0
Spain
State/province [163] 0 0
Vizcaya
Country [164] 0 0
Spain
State/province [164] 0 0
La Coruña
Country [165] 0 0
Spain
State/province [165] 0 0
Madrid
Country [166] 0 0
Spain
State/province [166] 0 0
Salamanca
Country [167] 0 0
Spain
State/province [167] 0 0
Sevilla
Country [168] 0 0
Spain
State/province [168] 0 0
Valencia
Country [169] 0 0
Sweden
State/province [169] 0 0
Göteborg
Country [170] 0 0
Sweden
State/province [170] 0 0
Lund
Country [171] 0 0
Sweden
State/province [171] 0 0
Stockholm
Country [172] 0 0
Sweden
State/province [172] 0 0
Umeå
Country [173] 0 0
Switzerland
State/province [173] 0 0
Basel
Country [174] 0 0
Switzerland
State/province [174] 0 0
Bellinzona
Country [175] 0 0
Switzerland
State/province [175] 0 0
Bern
Country [176] 0 0
Switzerland
State/province [176] 0 0
Biel
Country [177] 0 0
Switzerland
State/province [177] 0 0
CH-4058 Basel
Country [178] 0 0
Switzerland
State/province [178] 0 0
CH-4101 Bruderholz
Country [179] 0 0
Switzerland
State/province [179] 0 0
CH-4410 Liesthal
Country [180] 0 0
Switzerland
State/province [180] 0 0
Chur
Country [181] 0 0
Switzerland
State/province [181] 0 0
Genève 14
Country [182] 0 0
Taiwan
State/province [182] 0 0
Taipei
Country [183] 0 0
Taiwan
State/province [183] 0 0
Taoyun
Country [184] 0 0
Thailand
State/province [184] 0 0
Bangkok
Country [185] 0 0
Turkey
State/province [185] 0 0
Capa
Country [186] 0 0
Turkey
State/province [186] 0 0
Cerrahpasa
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Cardiff
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Se1 9rt
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Surrey
Country [190] 0 0
United Kingdom
State/province [190] 0 0
West Yorkshire
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Belfast
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Birmingham
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Bristol
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Cottingham
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Edinburgh
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Guildford
Country [197] 0 0
United Kingdom
State/province [197] 0 0
London
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Manchester
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Northwood
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Nottingham
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Sheffield
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Southampton
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Swansea
Country [204] 0 0
Venezuela
State/province [204] 0 0
Distrito Capital
Country [205] 0 0
Venezuela
State/province [205] 0 0
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/study/NCT00130897
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.
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/study/NCT00130897