Kidney Neoplasms
Conditions
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.
Interventions
DRUGSU-011,248
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed