7 results
PHASE IIPrimary ObjectiveThe primary objective of the Phase II portion of the study is to estimate the efficacy as measured by radiographic progression-free survival of IPATASERTIB (GDC-0068) (dosed at either 400 mg or 200 mg daily) + abiraterone…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
Currently, no robust clinical data are available comparing interventional ablation strategies in the setting of persistent AF with enlarged Atrium > 4 cm and longstanding persistent AF, which reflects a difficult to treat patient-subgroup.…
Lead in phase 1Primary objective:• To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination with R-DHAPSecondary objective:• To assess the toxicity of brentuximab vedotin in combination with R-DHAP• To…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP, each followed by radiotherapy on PET-positive residual lesions, in terms of progression free survival (…
• Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor and non-target lesions or -organs.• Establish safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of…