Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
Phase 2
Completed
- Conditions
- Kidney Neoplasms
- Registration Number
- NCT00054886
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Madison, Wisconsin, United States