5 results
To describe and compare pharmacokinetics of everolimus in a 10 mg QD and everolimus 5mg BID schedule, evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax.
The purpose of this study is to evaluate the efficacy and safety of MDV3100, a novel potent androgen-receptor antagonist without known agonist activity, in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who…
1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response rate of the pembrolizumab combination therapy. PSA response is defined as a reduction in the PSA level of 50% or…
1) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus enzalutamide versus placebo plus enzalutamide with respect to radiographic progression-free survival…
Primary Objective- To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central reviewMain Secondary Objectives- To determine the benefit of…