5 results
Primary objective:To characterize the clearance pathways, the route of excretion and the total recovery of radioactivity, PBI-4050 and its major metabolites in healthy subjects following administration of a single oral dose of 1200 mg [14C]-PBI-4050…
Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…
This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…
To compare PFS of subjects with newly-diagnosed MGMT methylated or indeterminate GBM subtypes treated with RT plus TMZ combined with nivolumab or placebo. PFS will be determined by BICR based on RANO criteria.To compare OS of subjects with newly-…
The aim of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of enzastaurin in preventing new arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to…