A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)

Outcome Description:

Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome Time Frame:

From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181006

NCT ID:

NCT00077974

Start Date:

February 2004

Completion Date:

September 2008

Related Keywords:

• Carcinoma, Renal Cell
• Carcinoma
• Carcinoma, Renal Cell