Conditions: Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: yes

Brief summary:
This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and lymphoma) that are refractory to standard therapy or for whom no standard therapy exists.

Detailed description:

Arms:
arm 1: Control cohort with normal renal and normal hepatic function arm 2: Severe renal impairment and normal hepatic function arm 3: Mild hepatic impairment and normal renal function arm 4: Moderate hepatic impairment and normal renal function arm 5: Severe hepatic impairment and normal renal function

Interventions: intervention 1: Vismodegib
Intervention descriptions: intervention 1: oral repeating dose of 150 mg once daily

Protocol document: