6 results
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
The primary objective of this study is to assess tolerance and efficacy of 12 weeks BP1.3656 (30 µg or 60 µg OD versus placebo) to reduce alcohol consumption in alcohol dependent patients.
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
The purpose of this study is to allow collection of safety and tolerability data in subjects benefitting from treatment with spartalizumab as a single agent or in combination with other study treatments in a pre-defined (Appendix Section 16.1)…
Primary: To characterize the safety and tolerability of LXH254 single agent and to identify recommended doses for future studies in adult patients with advanced solid tumors harboring MAPK pathway alterations.To characterize the safety and…