6 results
The main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
The aims of the study are (1) to establish the feasibility, safety, and potential efficacy of NcAcc DBS in patients with a chronic, treatment refractory heroin and/or cocaine addiction; (2) to explore functional effects of NcAcc DBS in terms of…
The key purpose of Safety lead in part of this study is to determine the maximum tolerable dose of anebumab ravtansine in combination with cisplatin for treatment of mesothelin-expressing cholangiocarcinoma, and similar for the combination with…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
Main objective: - Evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor and a P-glycoprotein (P-gp) inhibitor, on the safety and tolerability (including "thorough" electrocardiogram [ECG] assessment) and…