Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma

Pfizer1 site in 1 country63 target enrollmentJanuary 2003

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Kidney Neoplasms
Sponsor: Pfizer
Enrollment: 63
Locations: 1
Primary Endpoint: The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Status: Completed
Last Updated: 19 years ago

The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

August 2004

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
•The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
•Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function

•Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
•Prior surgical resection of or irradiation to the only site of measurable disease;
•Ongoing severe hematuria;
•Other active second malignancy;
•Cardiovascular diseases or conditions within the last 12 months;
•Known brain metastases;
•Known HIV-positive or AIDS-related illness;
•Pregnant or breast-feeding women;
•Current participation in other clinical trials;
•Other severe acute or chronic medical conditions.

The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.

The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.