8 results
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…
Primary:-To assess the mass balance profile (ie, excretion in urine and feces) of orteronel after a single oral dose of 400 mg orteronel containing 18.5 kBq (500 nCi) of 14[C]-orteronel-To characterize the pharmacokinetic profile of total…
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
Primary objectives: To assess the feasibility, accuracy and safety of preoperative SPECT/CT and intraoperative fluorescence imaging after administration of 111In-labetuzumab-IRDye800CW in patients with PC of colorectal origin who will undergo…
2.2 Primary ObjectiveTo study clinical factors, (blood) biomarkers and genetic markers related to AF progression in patients diagnosed with recent onset self-terminating AF with special reference to hypercoagulability.2.3 Secondary Objectives1. To…
To examine the safety, tolerability, and pharmacokinetic profile of single ascending doses of AZ-009 compared to placebo (part B and C) or to Apo-Go (part A) in healthy volunteers being pretreated with domperidone and in patients with Parkinson…
To study the incidence of 'sustained' ventricular tachyarrhythmias in patients with HFpEF.