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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00130897
First received: August 14, 2005
Last updated: March 8, 2012
Last verified: March 2012

August 14, 2005
March 8, 2012
July 2005
November 2011   (final data collection date for primary outcome measure)
Not Provided
Evaluation of overall response rate will be conducted according to RECIST criteria.
Complete list of historical versions of study NCT00130897 on ClinicalTrials.gov Archive Site
Not Provided
TTP, PFS, OS, safety and toleration
Not Provided
Not Provided
 
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
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.

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.

Expanded Access
Not Provided
Not Provided
Carcinoma, Renal Cell
Drug: Sutent
Sutent, 25, 37.5. or 50 mg daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
Not Provided
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • current treatment in another therapeutic clinical trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United States,   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,   Venezuela,   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
 
NCT00130897
A6181037
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP