7 results
Objectives:Primary Objectives:1. To evaluate the efficacy of BAN2401 compared to placebo by establishing the ED90 (as defined in theprotocol) for BAN2401 on the derived Composite Clinical Score at 12 months of treatment in subjects withEarly…
PrimaryTo assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progressionSecondaryTo assess other measures of efficacy of LEE011 compared with placebo To assess safety and tolerability of…
The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…
* To evaluate the effect of EDP1815 on the systemic immune system.* To evaluate the safety and tolerability of EDP1815 in multiple formulations.
Primary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (two dose levels using EC2 capsules) on the immune system.Secondary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (…
Investigation of the immune response following immunization with Immucothel/Alhydrogel with or without tetanus. Per efficacy endpoint, the following parameters will be explored:(a) Response size;(b) Inter-individual variability of the response;(c)…
Primary objective: Progression free survival (PFS) of treatment with letrozole plus LEE011 compared to treatment with letrozole plus placebo .Secondary objectives: Overall survival (OS), overall response rate (OR), overall clinical benefit rate,…