33 results
Primary:To identify the recommended dose of sorafenib and of sirolimus for combination therapy in subsequent phase II trials Secondary:1. to determine the safety profile of the combination therapy of sorafenib with sirolimus.2. to determine, if…
Primary objectivesDetermine the effect of Sorafenib (Bay 43-9006) on the uptake of In-111 labeled chimeric monoclonal antibody G250 (In-111-cG250) by RCC lesions.Determine the effect of Sorafenib (Bay 43-9006) on the uptake of In-111 labeled…
Primary:•Efficacy of combination of erlotinib and sorafenib as determined by the rate of no progression at 6 weeks.•Determination of the impact of concomitant administration of sorafenib on the pharmacokinetics (PK) of erlotinibSecondary:•Efficacy…
Objectives Primary end point:- to define the MTD of IL-2, subcutaneously given once a day, 5 days per week, for 6 weeks, in combination with a fixed dose of sorafenib in patients with metastatic RCC, clear cell subtype. Secondary end points:- the…
The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…
Primary:To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib.Secondary:1. Time from…
Primary Objectives: - To determine the maximum tolerated plasma AUC0-12h of high-dose sorafenib administered in a weekly, pulsatile schedule.- To assess the safety and tolerability of high-dose, pulsatile sorafenib. Secondary Objectives:- To…
The purpose of this study is to evaluate the efficacy and safety of fevipiprant 150 mg and 450 mg compared to placebo in the reduction of nasal polyps size and the effect on symptoms, quality of life and smell via patient-reported outcomes in…
The overall purpose of this study is to provide long-term safety data for fevipiprant (QAW039) (150 mg once daily and 450 mg once daily),compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care…
To demonstrate the bioequivalence of sorafenib with probenecid relative to sorafenib without probenecid based on the AUC in patients with unresectable hepatocellular cancer, advanced clear-cell renal cell carcinoma, locally recurrent or metastatic,…
We compare the efficacy and safety of the new medication MTL-CEBPA in combination with sorafenib with the efficacy and safety of sorafenib alone. Sorafenib is already being used for the treatment of HCC.
In patients with severe asthma and high eosinophil counts (>=250 cells/µl) receiving SoC asthma therapy, to demonstrate the efficacy (as measuredby rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg…
The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. An secondary objective is to…