Carcinoma, Renal CellNCT00130897
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
A study testing Sutent in people with Carcinoma, Renal Cell, run by Pfizer at 271 sites in 50 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Sutent
- How many people
- Not given
- Where
- 271 sitesin 50 countries
- Study dates
- Jul 2005to Nov 2011
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal cell carcinoma that is not amendable to standard therapy with curative intent
Who cannot join
- current treatment in another therapeutic clinical trial
Trial locations and contacts
271 sites in 50 countries.
271 sites in 50 countries
United States53 sites
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Aurora, Colorado, 80040-0510
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Columbia, Missouri, 65201
Pfizer Investigational Site
Columbia, Missouri, 65203
Pfizer Investigational Site
Council Bluffs, Iowa, 51503
Pfizer Investigational Site
Covington, Louisiana, 70433
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Gretna, Louisiana, 70056
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850
Pfizer Investigational Site
Indianapolis, Indiana, 46260-2082
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Marrero, Louisiana, 70072
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
Norman, Oklahoma, 73071
Pfizer Investigational Site
Norwalk, Connecticut, 06856
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73102
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73109
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120
Pfizer Investigational Site
Omaha, Nebraska, 68198-7680
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Portland, Oregon, 97227
Pfizer Investigational Site
Salt Lake City, Utah, 84112
Pfizer Investigational Site
San Francisco, California, 94115-2378
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Scottsdale, Arizona, 85260
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98109
Pfizer Investigational Site
Seattle, Washington, 98122
Pfizer Investigational Site
Seattle, Washington, 98124
Pfizer Investigational Site
Southaven, Mississippi, 38671
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
The Bronx, New York, 10466
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Tulsa, Oklahoma, 74136-1902
Pfizer Investigational Site
Tupelo, Mississippi, 38801
United Kingdom20 sites
Pfizer Investigational Site
Belfast, BT9 7AB
Pfizer Investigational Site
Birmingham, B15 2TH
Pfizer Investigational Site
Birmingham, B15 2TT
Pfizer Investigational Site
Bristol, BS2 8ED
Pfizer Investigational Site
Cottingham, HU16 5JQ
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
Guildford, GU2 5XX
Pfizer Investigational Site
Leeds, West Yorkshire, LS9 7TF
Pfizer Investigational Site
London, Se1 9rt
Pfizer Investigational Site
London, EC1A 7BE
Pfizer Investigational Site
London, NW3 2Qg
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
Manchester, M20 4BX
Pfizer Investigational Site
Northwood, HA6 2RN
Pfizer Investigational Site
Nottingham, NG5 1PB
Pfizer Investigational Site
Sheffield, S10 2SJ
Pfizer Investigational Site
Southampton, SO16 6YD
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
Pfizer Investigational Site
Swansea, SA2 8QA
Pfizer Investigational Site
Whitchurch, Cardiff, CF14 2TL
Italy17 sites
Pfizer Investigational Site
Bergamo, 24128
Pfizer Investigational Site
Brescia, 25123
Pfizer Investigational Site
Cattolica (RN), 47841
Pfizer Investigational Site
Cuneo, 12100
Pfizer Investigational Site
Legnago, VR, 37045
Pfizer Investigational Site
Modena, 41100
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Padova, 35128
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Pavia, 27100
Pfizer Investigational Site
Perugia, 06132
Pfizer Investigational Site
Pordenone, 33170
Pfizer Investigational Site
Rimini, 47900
Pfizer Investigational Site
Roma, 00135
Pfizer Investigational Site
Roma, 00144
Pfizer Investigational Site
Roma, 00152
Pfizer Investigational Site
Torino, 10126
Canada16 sites
Pfizer Investigational Site
Calgary, Alberta, T2N 4N2
Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 5L3
Pfizer Investigational Site
London, Ontario, N6A 4L6
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
Québec, Quebec, G1R 2J6
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5G 2M9
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E6
Pfizer Investigational Site
Victoria, British Columbia, V8R 6V5
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 0V9
Pfizer Investigational Site
Winnnipeg, Manitoba, R2H 2A6
Germany15 sites
Pfizer Investigational Site
Aachen, 52074
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Essen, 45122
Pfizer Investigational Site
Frankfurt, 60590
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Hamburg, 20246
Pfizer Investigational Site
Hanover, 30625
Pfizer Investigational Site
Homburg/Saar, 66421
Pfizer Investigational Site
Jena, 07740
Pfizer Investigational Site
Kassel, 34125
Pfizer Investigational Site
München, 81664
Pfizer Investigational Site
Nuremberg, 90419
Pfizer Investigational Site
Rostock, 18057
Pfizer Investigational Site
Ulm, 89081
France14 sites
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Clermont Ferand, 63011
Pfizer Investigational Site
Lyon, Cedex 08, 69008
Pfizer Investigational Site
Marseille, 13273
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Montpellier, 34298 cedex 05
Pfizer Investigational Site
Paris, 75651
Pfizer Investigational Site
Paris, 75908
Pfizer Investigational Site
Reims, 51100
Pfizer Investigational Site
Rennes, 35042
Pfizer Investigational Site
Saint-Herblain, Cedex, 44805
Pfizer Investigational Site
Strasbourg, Cedex, 67091
Pfizer Investigational Site
Tours, 37044
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511
Spain13 sites
Pfizer Investigational Site
A Coruña, La Coruña, 15006
Pfizer Investigational Site
Barakaldo, Vizcaya, 48903
Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
L'hospitalet Del Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33006
Pfizer Investigational Site
Pamplona, Navarre, 31008
Pfizer Investigational Site
Salamanca, Salamanca, 37007
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Valencia, Valencia, 46009
Brazil11 sites
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30380-490
Pfizer Investigational Site
Jaú, São Paulo, 17210-080
Pfizer Investigational Site
Jaú, São Paulo, 17210-120
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90020-090
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20231-050
Pfizer Investigational Site
Salvador, Estado de Bahia, 41950-640
Pfizer Investigational Site
São Paulo, São Paulo, 01308-050
Pfizer Investigational Site
São Paulo, São Paulo, 01509-900
Pfizer Investigational Site
São Paulo, São Paulo, 05651-000
Australia9 sites
Pfizer Investigational Site
East Melbourne, Victoria, 3002
Pfizer Investigational Site
Elizabeth Vale, South Australia, 5112
Pfizer Investigational Site
Heidelburg, Victoria, 3084
Pfizer Investigational Site
Perth, Western Australia, 6000
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
South Brisbane, Queensland, 4101
Pfizer Investigational Site
St Leonards, New South Wales, 2065
Pfizer Investigational Site
Westmead, New South Wales, 2145
Pfizer Investigational Site
Woodville South, South Australia, 5011
Switzerland9 sites
Pfizer Investigational Site
Basel, CH-4056
Pfizer Investigational Site
Bellinzona, CH-6500
Pfizer Investigational Site
Bern, 3010
Pfizer Investigational Site
Biel, 2500
Pfizer Investigational Site
Ch-4058 Basel
Pfizer Investigational Site
Ch-4101 Bruderholz
Pfizer Investigational Site
Ch-4410 Liesthal
Pfizer Investigational Site
Chur, CH-7000
Pfizer Investigational Site
Geneva, CH-1211
Mexico7 sites
Pfizer Investigational Site
Chihuahua City, Chihuahua, 31000
Pfizer Investigational Site
Guadalajara, Jalisco, 44240
Pfizer Investigational Site
Mérida, Yucatán, 97000
Pfizer Investigational Site
Mexico City, Mexico City, 06720
Pfizer Investigational Site
Mexico City, Mexico City, 14000
Pfizer Investigational Site
Puebla City, Puebla, 72530
Pfizer Investigational Site
Toluca, State of Mexico, 50180
Belgium6 sites
Pfizer Investigational Site
Brussels, 1000
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, 4000
Pfizer Investigational Site
Wilrijk, 2610
India5 sites
Pfizer Investigational Site
Jaipur, Rajasthan, 302 004
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, 110 029
Pfizer Investigational Site
New Delhi, 110 085
Pfizer Investigational Site
Parel, Mumbai, 400 012
Pfizer Investigational Site
Pune, Maharashtra, 411 004
Poland5 sites
Pfizer Investigational Site
Gdansk, 80-210
Pfizer Investigational Site
Lodz, 93-509
Pfizer Investigational Site
Poznan, 60-569
Pfizer Investigational Site
Warsaw, 00-909
Pfizer Investigational Site
Wroclaw, 50-556
Czechia4 sites
Pfizer Investigational Site
Brno, 656 53
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Prague, 150 06
Pfizer Investigational Site
Prague, 180 00
Greece4 sites
Pfizer Investigational Site
Athens, Attica, 115 22
Pfizer Investigational Site
Athens, 11528
Pfizer Investigational Site
Pátrai, 26500
Pfizer Investigational Site
Thessaloniki, 540 07
Netherlands4 sites
Pfizer Investigational Site
Amsterdam, North Holland, 1066 CX
Pfizer Investigational Site
Amsterdam, 1081 HV
Pfizer Investigational Site
Groningen, Provincie Groningen, 9713 GZ
Pfizer Investigational Site
Rotterdam, 3075 EA
Sweden4 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Lund, 221 85
Pfizer Investigational Site
Stockholm, 171 76
Pfizer Investigational Site
Umeå, 901 85
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, C1034ACO
Pfizer Investigational Site
Buenos Aires, C1426ANZ
Pfizer Investigational Site
Buenos Aires, C1431FWO
Russia3 sites
Pfizer Investigational Site
Chelyabinsk, 454087
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Obninsk, Kaluga Oblast, 249036
Taiwan3 sites
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taoyun, 333
Austria2 sites
Pfizer Investigational Site
Innsbruck, 6020
Pfizer Investigational Site
Vienna, 1090
Bulgaria2 sites
Pfizer Investigational Site
Sofia, Bulgaria, 1504
Pfizer Investigational Site
Sofia, 1756
Colombia2 sites
Pfizer Investigational Site
Bogotá, Cundinamarca, 0000
Pfizer Investigational Site
Cali
Croatia2 sites
Pfizer Investigational Site
Rijeka, 51000
Pfizer Investigational Site
Split, 21000
Ecuador2 sites
Pfizer Investigational Site
Guayaquil, Guayas
Pfizer Investigational Site
Quito, Pichincha
Israel2 sites
Pfizer Investigational Site
Jerusalem
Pfizer Investigational Site
Tel HaShomer, 52621
Malaysia2 sites
Pfizer Investigational Site
Kuala Lumpur, 59100
Pfizer Investigational Site
Petaling Jaya, Selangor, 46050
Peru2 sites
Pfizer Investigational Site
Lima, Lima Province, 11
Pfizer Investigational Site
Lima, Lima Province, L13
Philippines2 sites
Pfizer Investigational Site
Quezon City, 1102
Pfizer Investigational Site
Quezon City
Portugal2 sites
Pfizer Investigational Site
Lisbon, 1070-213
Pfizer Investigational Site
Porto, 4200-319
Romania2 sites
Pfizer Investigational Site
Bucharest, 022328
Pfizer Investigational Site
Cluj-Napoca, 400015
Slovakia2 sites
Pfizer Investigational Site
Bratislava, 83301
Pfizer Investigational Site
Žilina, 012 07
South Korea2 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-753
Thailand2 sites
Pfizer Investigational Site
Bangkok, 10330
Pfizer Investigational Site
Bangkok, 10700
Turkey (Türkiye)2 sites
Pfizer Investigational Site
Istanbul, Capa, 34390
Pfizer Investigational Site
Istanbul, Cerrahpasa, 34303
Venezuela2 sites
Pfizer Investigational Site
Caracas, Distrito Federal, 1040
Pfizer Investigational Site
Caracas, Miranda, 1060
Bosnia and Herzegovina1 site
Pfizer Investigational Site
Sarajevo, 71000
Slovenia1 site
Pfizer Investigational Site
Ljubljana, Ljubljana, 1000 Ljubljana
About this study
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
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.
Read the detailed 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.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sutent
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutentDrug
Sutent, 25, 37.5. or 50 mg daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130897
- Sponsor's protocol ID
- A6181037
- Status last verified
- Mar 2012
- First submitted
- 14 Aug 2005
- Last updated
- 9 Mar 2012
- Results posted
- No
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.
PubMed 27713637Lee 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.
PubMed 24576311Gore 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.
PubMed 20862748Gore 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.
PubMed 19615940
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00130897
- Acronym / sponsor ID
- A6181037
- Conditions
- Carcinoma, Renal Cell
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- renal cell carcinoma that is not amendable to standard therapy with curative intent
Key exclusion criteria (1 listed)
- current treatment in another therapeutic clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SutentSutent, 25, 37.5. or 50 mg daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 27713637Barrios 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.
- Derived from this study: PubMed 24576311Lee 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.
- Derived from this study: PubMed 20862748Gore 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.
- Derived from this study: PubMed 19615940Gore 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
271 sites in 50 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutent in people with Carcinoma, Renal Cell, run by Pfizer at 271 sites in 50 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 271 sites in United States, United Kingdom, Italy, Canada, Germany and 45 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00130897, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.