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

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ClinicalTrials.gov Identifier: NCT00130897
Recruitment Status : Approved for marketing
First Posted : August 16, 2005
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Carcinoma, Renal Cell Drug: Sutent

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 Type : Expanded Access
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
Study Start Date : July 2005
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • current treatment in another therapeutic clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130897


  Show 274 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00130897     History of Changes
Other Study ID Numbers: A6181037
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors