Carcinoma, Renal Cell Clinical Trial
Official 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
| 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 |
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.
| 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 |
N/A
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
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,
| 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 |
NCT00356460 -
Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma
|
Phase 1 | |
| 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 |
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 |