6 results
Primary:* To compare overall survival (OS) in subjects with advanced soft tissue sarcoma ([STS], one of two subtypes: adipocytic [ADI] or leiomyosarcoma [LMS]) when treated with eribulin (Arm A) or dacarbazine (Arm B).Secondary:* To compare…
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• To determine the safety profile of oral topotecan in subjects with cancer andmildly moderately or severely impaired renal function (Groups C, D and E) compared to subjects with cancerwhose renal function is normal and who have received…
The primary objective is to assess treatment with rovalpituzumab tesirine improves overall survival rate (OS) compared to topotecan in subjects with DLL3high SCLC who have first disease progression during or following front-line platinum based…