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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Kidney Neoplasms

Treatments: Drug: SU-011,248

Study type: Interventional

Funder types: Industry

Identifiers

NCT00054886

RTKC-0511-014

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)