8 results
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
Primary objective:To determine whether there is a difference in overall survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control armconsisting of best Investigator's choice between cyclophosphamide (CTX), doxorubicin (DOX)…
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…
Part 1: To evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks.Part 2: evaluate long-term safety profile of BIIB033 as an add-on therapy in subjects with MS.
Primary:- To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide or irinotecan-temozolomide or topotecan-temozolomide) demonstrates activity in children with relapsed or refractory neuroblastoma- To test whether the…
Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…
This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…
Primary Objective:• To compare the progression-free survival (PFS) of patients randomized to mirvetuximab soravtansine (MIRV) vs. Investigator*s choice of chemotherapy (IC Chemo) Key Secondary Objectives:• To compare the objective response rate (ORR…