NCT01546519

A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function

A Phase Ib Open-Label Pharmacokinetics and Safety Study of the Hedgehog Pathway Inhibitor Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Vismodegib	oral repeating dose of 150 mg once daily

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-03-07
• Last updated: 2016-05-23
• Results posted: 2016-05-23

Locations

5 sites across 1 country: United States