Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.