4 results
Primary Objective• To evaluate best overall response rate (BORR; CR + PR) in Cohort 1 (TKI-naïve patients).* BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST…
First, to demonstrate whether UDCA-therapy is effective in reducing total liver volume in PLD patients. Second, we want to assess if UDCA modifies quality of life. Finally, we want to assess safety and tolerability.
This study is intended to establish a dose response rate of MR30507/09 with respect to respiratory effects compared to MR30365/07, fentanyl and placebo..
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…