Clinical Trials Logo

Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT00130897
Other study ID # A6181037
Secondary ID
Status Approved for marketing
Phase N/A
First received August 14, 2005
Last updated March 8, 2012
Start date July 2005
Est. completion date November 2011

Study information

Verified date March 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.


Description:

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181037 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- renal cell carcinoma that is not amendable to standard therapy with curative intent

Exclusion Criteria:

- current treatment in another therapeutic clinical trial

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Sutent
Sutent, 25, 37.5. or 50 mg daily

Locations

Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Australia Pfizer Investigational Site East Melbourne Victoria
Australia Pfizer Investigational Site Elizabeth Vale South Australia
Australia Pfizer Investigational Site Heidelburg Victoria
Australia Pfizer Investigational Site Perth Western Australia
Australia Pfizer Investigational Site Randwick New South Wales
Australia Pfizer Investigational Site South Brisbane Queensland
Australia Pfizer Investigational Site St Leonards New South Wales
Australia Pfizer Investigational Site Westmead New South Wales
Australia Pfizer Investigational Site Woodville South South Australia
Austria Pfizer Investigational Site Innsbruck
Austria Pfizer Investigational Site Wien
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Leuven
Belgium Pfizer Investigational Site Liege
Belgium Pfizer Investigational Site Wilrijk
Bosnia and Herzegovina Pfizer Investigational Site Sarajevo
Brazil Pfizer Investigational Site Belo Horizonte MG
Brazil Pfizer Investigational Site Jau SP
Brazil Pfizer Investigational Site Jaú SP
Brazil Pfizer Investigational Site Jaú SP
Brazil Pfizer Investigational Site Porto Alegre Rio Grande do Sul
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Rio de Janeiro RJ
Brazil Pfizer Investigational Site Rio de Janeiro RJ
Brazil Pfizer Investigational Site Salvador BA
Brazil Pfizer Investigational Site São Paulo SP
Brazil Pfizer Investigational Site São Paulo SP
Brazil Pfizer Investigational Site São Paulo SP
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Sofia
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site St. John's Newfoundland and Labrador
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Victoria British Columbia
Canada Pfizer Investigational Site Winnipeg Manitoba
Canada Pfizer Investigational Site Winnnipeg Manitoba
Chile Pfizer Investigational Site Santiago RM
Colombia Pfizer Investigational Site Bogotá Cundinamarca
Colombia Pfizer Investigational Site Cali
Croatia Pfizer Investigational Site Rijeka
Croatia Pfizer Investigational Site Split
Czech Republic Pfizer Investigational Site Brno
Czech Republic Pfizer Investigational Site Hradec Kralove
Czech Republic Pfizer Investigational Site Praha 5
Czech Republic Pfizer Investigational Site Praha 8
Ecuador Pfizer Investigational Site Guayaquil Guayas
Ecuador Pfizer Investigational Site Quito Pichincha
Egypt Pfizer Investigational Site Cairo
Egypt Pfizer Investigational Site Giza
Finland Pfizer Investigational Site Turku
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Clermont Ferand
France Pfizer Investigational Site Lyon Cedex 08
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille Cedex 9
France Pfizer Investigational Site Montpellier
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris Cedex 13
France Pfizer Investigational Site Reims
France Pfizer Investigational Site Rennes
France Pfizer Investigational Site Saint Herblain Cedex
France Pfizer Investigational Site Strasbourg Cedex
France Pfizer Investigational Site Tours
France Pfizer Investigational Site Vandoeuvre les Nancy
Germany Pfizer Investigational Site Aachen
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Dresden
Germany Pfizer Investigational Site Essen
Germany Pfizer Investigational Site Frankfurt
Germany Pfizer Investigational Site Freiburg
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Hannover
Germany Pfizer Investigational Site Homburg/Saar
Germany Pfizer Investigational Site Jena
Germany Pfizer Investigational Site Kassel
Germany Pfizer Investigational Site Muenchen
Germany Pfizer Investigational Site Nuernberg
Germany Pfizer Investigational Site Rostock
Germany Pfizer Investigational Site Ulm
Greece Pfizer Investigational Site Athens Attiki
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Patras
Greece Pfizer Investigational Site Thessaloniki
Hong Kong Pfizer Investigational Site Hong Hong
Hungary Pfizer Investigational Site Budapest
India Pfizer Investigational Site Jaipur Rajasthan
India Pfizer Investigational Site New Delhi
India Pfizer Investigational Site New Delhi Delhi
India Pfizer Investigational Site Parel Mumbai
India Pfizer Investigational Site Pune Maharashtra
Ireland Pfizer Investigational Site Dublin
Ireland Pfizer Investigational Site Dublin 24
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Tel Hashomer
Italy Pfizer Investigational Site Bergamo
Italy Pfizer Investigational Site Brescia
Italy Pfizer Investigational Site Cattolica (RN)
Italy Pfizer Investigational Site Cuneo
Italy Pfizer Investigational Site Legnago, VR
Italy Pfizer Investigational Site Modena
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Padova
Italy Pfizer Investigational Site Parma
Italy Pfizer Investigational Site Pavia
Italy Pfizer Investigational Site Perugia
Italy Pfizer Investigational Site Pordenone
Italy Pfizer Investigational Site Rimini
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Torino
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Lebanon Pfizer Investigational Site Beirut
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Petaling Jaya Selangor
Mexico Pfizer Investigational Site Chihuahua
Mexico Pfizer Investigational Site Guadalajara Jalisco
Mexico Pfizer Investigational Site Merida Yucatan
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Mexico DF
Mexico Pfizer Investigational Site Puebla
Mexico Pfizer Investigational Site Toluca Estado de Mexico
Netherlands Pfizer Investigational Site Amsterdam NH
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Groningen GR
Netherlands Pfizer Investigational Site Rotterdam
Norway Pfizer Investigational Site Oslo
Panama Pfizer Investigational Site Ciudad de Panama
Panama Pfizer Investigational Site Panama
Peru Pfizer Investigational Site Lima
Peru Pfizer Investigational Site Lima
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Poland Pfizer Investigational Site Gdansk
Poland Pfizer Investigational Site Lodz
Poland Pfizer Investigational Site Poznan
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Wroclaw
Portugal Pfizer Investigational Site Lisboa
Portugal Pfizer Investigational Site Porto
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Cluj-Napoca
Russian Federation Pfizer Investigational Site Chelyabinsk
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Obninsk Kaluga region
Serbia Pfizer Investigational Site Belgrade
Singapore Pfizer Investigational Site Singapore
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Zilina
Slovenia Pfizer Investigational Site Ljubljana
Spain Pfizer Investigational Site Baracaldo Vizcaya
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'hospitalet Del Llobregat Barcelona
Spain Pfizer Investigational Site La Coruña
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Oviedo Asturias
Spain Pfizer Investigational Site Pamplona Navarra
Spain Pfizer Investigational Site Salamanca
Spain Pfizer Investigational Site Sevilla
Spain Pfizer Investigational Site Valencia
Sweden Pfizer Investigational Site Göteborg
Sweden Pfizer Investigational Site Lund
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Umeå
Switzerland Pfizer Investigational Site Basel
Switzerland Pfizer Investigational Site Bellinzona
Switzerland Pfizer Investigational Site Bern
Switzerland Pfizer Investigational Site Biel
Switzerland Pfizer Investigational Site CH-4058 Basel
Switzerland Pfizer Investigational Site CH-4101 Bruderholz
Switzerland Pfizer Investigational Site CH-4410 Liesthal
Switzerland Pfizer Investigational Site Chur
Switzerland Pfizer Investigational Site Genève 14
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taipei
Taiwan Pfizer Investigational Site Taoyun
Thailand Pfizer Investigational Site Bangkok
Thailand Pfizer Investigational Site Bangkok
Turkey Pfizer Investigational Site Istanbul Capa
Turkey Pfizer Investigational Site Istanbul Cerrahpasa
United Kingdom Pfizer Investigational Site Belfast
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Cottingham
United Kingdom Pfizer Investigational Site Edinburgh
United Kingdom Pfizer Investigational Site Guildford
United Kingdom Pfizer Investigational Site Leeds West Yorkshire
United Kingdom Pfizer Investigational Site London Se1 9rt
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Northwood
United Kingdom Pfizer Investigational Site Nottingham
United Kingdom Pfizer Investigational Site Sheffield
United Kingdom Pfizer Investigational Site Southampton
United Kingdom Pfizer Investigational Site Sutton Surrey
United Kingdom Pfizer Investigational Site Swansea
United Kingdom Pfizer Investigational Site Whitchurch Cardiff
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbia Missouri
United States Pfizer Investigational Site Columbia Missouri
United States Pfizer Investigational Site Council Bluffs Iowa
United States Pfizer Investigational Site Covington Louisiana
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Gretna Louisiana
United States Pfizer Investigational Site Hershey Pennsylvania
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Marrero Louisiana
United States Pfizer Investigational Site Maywood Illinois
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Metairie Louisiana
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Norman Oklahoma
United States Pfizer Investigational Site Norwalk Connecticut
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Scottsdale Arizona
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Southaven Mississippi
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Tupelo Mississippi
Venezuela Pfizer Investigational Site Caracas Distrito Capital
Venezuela Pfizer Investigational Site Caracas Estado Miranda

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czech Republic,  Ecuador,  Egypt,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Netherlands,  Norway,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

See also
  Status Clinical Trial Phase
Completed NCT02248389 - Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses Phase 1
Completed NCT03900364 - a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy N/A
Completed NCT00158782 - Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients Phase 1
Completed NCT03109015 - Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing Phase 2
Completed NCT00363194 - A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients Phase 1
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Completed NCT00842790 - Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging N/A
Completed NCT00529802 - Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer Phase 2
Completed NCT00387764 - Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer Phase 3
Completed NCT00338884 - Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer Phase 2
Completed NCT00356460 - Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma Phase 1
Completed NCT00095186 - Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma Phase 2
Completed NCT00079612 - Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer Phase 2
Completed NCT00043368 - PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909) Phase 2
Active, not recruiting NCT04489771 - A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) Phase 2
Completed NCT00516672 - Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors Phase 1
Withdrawn NCT05104905 - A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1
Withdrawn NCT03111901 - Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer Phase 1/Phase 2
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1