9 results
Primary Study Objective: To evaluate the effect of telotristat etiprate versus placebo over the double-blind portion of the study on the incidence of treatment-emergent adverse events (TEAEs)
To test the use of RFA and ER in a single endoscopic session in 20 consecutive patients with a BE containing visible abnormalities with HGD or EC upon biopsy.
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…
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 (…
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…
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week…
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 primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.The secondary objective is to evaluate changes in patients* quality of life (QOL) through week 84.
• 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…