This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
Progression Free Survival
Time frame: 2 3/4 years
Objective response rate (ORR)
Time frame: 2 3/4 years
Duration of response (DOR)
Time frame: 2 3/4 years
Change in continuous measures of tumor burden
Time frame: 2 3/4 years
Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data
Time frame: 2 3/4 years
Incidence of AEs and significant laboratory changes
Time frame: 2 3/4 years
Incidence of the occurrence of anti-AMG 386 antibody formation
Time frame: 2 3/4 years
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