7 results
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…
The objectives of this study are to demonstrate that Nepafenac Ophthalmic Suspension, 0.3% is not inferior to Nepafenac Ophthalmic Suspension, 0.1% (NEVANAC®); Nepafenac Ophthalmic Suspension, 0.3% is superior to Nepafenac 0.3% Vehicle and NEVANAC…
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 (…
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…
The purpose of Part A is to investigate how quickly and to what extent Rizatriptan in DFN-10 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, it will be investigated to what extent DFN-10 is tolerated.In Part…
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…
• 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…