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…
To assess the bioequivalence of two marketed formulations of ribavirin (ribavirin solution and capsules).
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…
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…