CClinicalTrials.gg
Approved for marketingNCT00130897Updated Mar 9, 2012

Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

An expanded access record providing Sutent in Carcinoma, Renal Cell, sponsored by Pfizer. Approved for marketing at 274 sites in 50 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Pfizer · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Carcinoma, Renal Cell
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

Browse Carcinoma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • current treatment in another therapeutic clinical trial
05

Access details

Study type
Expanded access

Available treatment

  • DrugSutent

    Sutent, 25, 37.5. or 50 mg daily

06

Where to request access

274 sites
  • Pfizer Investigational Site
    Scottsdale, Arizona 85260, United States
  • Pfizer Investigational Site
    San Francisco, California 94115-2378, United States
  • Pfizer Investigational Site
    San Francisco, California 94115, United States
  • Pfizer Investigational Site
    Aurora, Colorado 80040-0510, United States
  • Pfizer Investigational Site
    Norwalk, Connecticut 06856, United States
  • Pfizer Investigational Site
    Miami, Florida 33176, United States
  • Pfizer Investigational Site
    Ocala, Florida 34474, United States
  • Pfizer Investigational Site
    Tampa, Florida 33612, United States
  • Pfizer Investigational Site
    Atlanta, Georgia 30309, United States
  • Pfizer Investigational Site
    Maywood, Illinois 60153, United States
  • Pfizer Investigational Site
    Indianapolis, Indiana 46260-2082, United States
  • Pfizer Investigational Site
    Council Bluffs, Iowa 51503, United States
  • Pfizer Investigational Site
    Covington, Louisiana 70433, United States
  • Pfizer Investigational Site
    Gretna, Louisiana 70056, United States
  • Pfizer Investigational Site
    Marrero, Louisiana 70072, United States
  • Pfizer Investigational Site
    Metairie, Louisiana 70002, United States
  • Pfizer Investigational Site
    Metairie, Louisiana 70006, United States
  • Pfizer Investigational Site
    New Orleans, Louisiana 70115, United States
  • Pfizer Investigational Site
    Baltimore, Maryland 21287, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02114, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02115, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02215, United States
  • Pfizer Investigational Site
    Detroit, Michigan 48201, United States
  • Pfizer Investigational Site
    Minneapolis, Minnesota 55455, United States
  • Pfizer Investigational Site
    Southaven, Mississippi 38671, United States
  • Pfizer Investigational Site
    Tupelo, Mississippi 38801, United States
  • Pfizer Investigational Site
    Columbia, Missouri 65201, United States
  • Pfizer Investigational Site
    Columbia, Missouri 65203, United States
  • Pfizer Investigational Site
    Omaha, Nebraska 68198-7680, United States
  • Pfizer Investigational Site
    Bronx, New York 10466, United States
  • Pfizer Investigational Site
    New York, New York 10021, United States
  • Pfizer Investigational Site
    New York, New York 10022, United States
  • Pfizer Investigational Site
    Durham, North Carolina 27710, United States
  • Pfizer Investigational Site
    Cleveland, Ohio 44195, United States
  • Pfizer Investigational Site
    Norman, Oklahoma 73071, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73102, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73109, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73112, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma 73120, United States
  • Pfizer Investigational Site
    Tulsa, Oklahoma 74104, United States
  • Pfizer Investigational Site
    Tulsa, Oklahoma 74136-1902, United States
  • Pfizer Investigational Site
    Portland, Oregon 97210, United States
  • Pfizer Investigational Site
    Portland, Oregon 97227, United States
  • Pfizer Investigational Site
    Hershey, Pennsylvania 17033-0850, United States
  • Pfizer Investigational Site
    Memphis, Tennessee 38104, United States
  • Pfizer Investigational Site
    Memphis, Tennessee 38120, United States
  • Pfizer Investigational Site
    Dallas, Texas 75246, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah 84112, United States
  • Pfizer Investigational Site
    Seattle, Washington 98104, United States
  • Pfizer Investigational Site
    Seattle, Washington 98109, United States
  • Pfizer Investigational Site
    Seattle, Washington 98122, United States
  • Pfizer Investigational Site
    Seattle, Washington 98124, United States
  • Pfizer Investigational Site
    Madison, Wisconsin 53792, United States
  • Pfizer Investigational Site
    Buenos Aires, C1034ACO, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1426ANZ, Argentina
  • Pfizer Investigational Site
    Buenos Aires, C1431FWO, Argentina
  • Pfizer Investigational Site
    Randwick, New South Wales 2031, Australia
  • Pfizer Investigational Site
    St Leonards, New South Wales 2065, Australia
  • Pfizer Investigational Site
    Westmead, New South Wales 2145, Australia
  • Pfizer Investigational Site
    South Brisbane, Queensland 4101, Australia
  • Pfizer Investigational Site
    Elizabeth Vale, South Australia 5112, Australia
  • Pfizer Investigational Site
    Woodville South, South Australia 5011, Australia
  • Pfizer Investigational Site
    East Melbourne, Victoria 3002, Australia
  • Pfizer Investigational Site
    Heidelburg, Victoria 3084, Australia
  • Pfizer Investigational Site
    Perth, Western Australia 6000, Australia
  • Pfizer Investigational Site
    Innsbruck, 6020, Austria
  • Pfizer Investigational Site
    Wien, 1090, Austria
  • Pfizer Investigational Site
    Bruxelles, 1000, Belgium
  • Pfizer Investigational Site
    Bruxelles, 1200, Belgium
  • Pfizer Investigational Site
    Gent, 9000, Belgium
  • Pfizer Investigational Site
    Leuven, 3000, Belgium
  • Pfizer Investigational Site
    Liege, 4000, Belgium
  • Pfizer Investigational Site
    Wilrijk, 2610, Belgium
  • Pfizer Investigational Site
    Sarajevo, 71000, Bosnia and Herzegovina
  • Pfizer Investigational Site
    Salvador, BA 41950-640, Brazil
  • Pfizer Investigational Site
    Belo Horizonte, MG 30380-490, Brazil
  • Pfizer Investigational Site
    Porto Alegre, Rio Grande do Sul 90020-090, Brazil
  • Pfizer Investigational Site
    Rio de Janeiro, RJ 20230-130, Brazil
  • Pfizer Investigational Site
    Rio de Janeiro, RJ 20231-050, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90610-000, Brazil
  • Pfizer Investigational Site
    Jau, SP 17210-120, Brazil
  • Pfizer Investigational Site
    Jaú, SP 17210-080, Brazil
  • Pfizer Investigational Site
    Jaú, SP 17210-120, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 01308-050, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 01509-900, Brazil
  • Pfizer Investigational Site
    São Paulo, SP 05651-000, Brazil
  • Pfizer Investigational Site
    Sofia, 1504, Bulgaria
  • Pfizer Investigational Site
    Sofia, 1756, Bulgaria
  • Pfizer Investigational Site
    Calgary, Alberta T2N 4N2, Canada
  • Pfizer Investigational Site
    Edmonton, Alberta T6G 1Z2, Canada
  • Pfizer Investigational Site
    Kelowna, British Columbia V1Y 5L3, Canada
  • Pfizer Investigational Site
    Vancouver, British Columbia V5Z 4E6, Canada
  • Pfizer Investigational Site
    Victoria, British Columbia V8R 6V5, Canada
  • Pfizer Investigational Site
    Winnipeg, Manitoba R3E 0V9, Canada
  • Pfizer Investigational Site
    Winnnipeg, Manitoba R2H 2A6, Canada
  • Pfizer Investigational Site
    St. John's, Newfoundland and Labrador A1B 3V6, Canada
  • Pfizer Investigational Site
    Halifax, Nova Scotia B3H 1V7, Canada
  • Pfizer Investigational Site
    Halifax, Nova Scotia B3H 2Y9, Canada
  • Pfizer Investigational Site
    London, Ontario N6A 4L6, Canada
  • Pfizer Investigational Site
    Toronto, Ontario M4N 3M5, Canada

Showing the first 100 of 274 sites across 50 countries.

07

References and documents

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 27713637 ↗
  • 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. PubMed 24576311 ↗
  • 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. PubMed 20862748 ↗
  • 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. PubMed 19615940 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00130897
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 16, 2005
Start date
Jul 2005
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Mar 9, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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