Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk in 2 cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks
Part 2, Cohort 1: Safety: Incidence and severity of AEs
Part 2, Cohort 2: Time to disease progression
Part 2, Cohort 1: Time to disease progression
Part 2, Cohorts 1 & 2: Survival time
Part 2, Cohorts 1 & 2: PFS
Part 2, Cohorts 1 & 2: Best overall response rate
Part 2, Cohorts 1 & 2: Tumor response rate at Weeks 15, 23, 31, and 39
Part 2, Cohorts 1 & 2: Duration of response
Part 2, Cohorts 1 & 2: Percent of patients with progressive disease (measured at 8 weeks following initiation of panitumumab treatment)
Part 2, Cohorts 1 & 2: Time to CR
Part 2, Cohorts 1 & 2: Time to response (PR or CR)
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