7 results
The primary objective is to confirm the diagnosis of biliary atresia by visualisation of the (remaining) biliary tract using fluorescence cholangiography.
Primary: Evaluate the ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard esophagus resection and lymphadenectomy procedure by the surgeon while detection of indocyanine green (ICG) takes…
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…
To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of progression-free survival (PFS) by independent review
Primary Objective:* To evaluate the safety of TAK-164 and to determine the MTD and/or RP2D.Part C (imaging substudy) secondary objectives are:* To determine the biodistribution of 89Zr-TAK-164 in patients with mCRC and/or metastatic gastric…
Primary objective:- To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives- To describe duration of response and overall…