Conditions: Carcinoma, Hepatocellular
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The aim of the study is to investigate the safety, tolerability, efficacy and pharmacokinetics (PK) for Japanese hepatocellular carcinoma which are not amenable to curative surgery or loco regional therapy

Detailed description:

Arms:
arm 1: patients with mild liver dysfunction according to their AST/ALT values and Child-Pugh score arm 2: patients with moderate liver dysfunction according to their AST/ALT values and Child-Pugh score

Interventions: intervention 1: Nintedanib high dose intervention 2: Nintedanib low dose intervention 3: Nintedanib medium dose intervention 4: Nintedanib medium dose intervention 5: Nintedanib high dose
Intervention descriptions: intervention 1: twice daily oral dosing intervention 2: twice daily oral dosing intervention 3: twice daily oral dosing intervention 4: twice daily oral dosing intervention 5: twice daily oral dosing

Protocol document: