6 results
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 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…
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 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…
The primary objective is to compare the efficacy of palifermin relative to placebo when given either pre-and post-high dose chemotherapy or pre-high dose chemotherapy only with regard to the severity of oral mucositis.
To increase familiarity with the biosensor and data derived from the sensor, we propose to measure TAVI patients in 3 different situations; 1) a measurement pre-TAVI in a home situation, 2) directly post-procedural inhospital and in the transition…