NCT00920192

Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer

A Phase 1/2, Open-Label, Multicenter Study of GSK1363089Gin Adult Subjects With Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer).

Detailed description

The purpose of this study is to identify the maximum tolerated dose (MTD) of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer), and to assess the safety and tolerability of that dose in this patient population. The MTD will be identified during Phase I, by standard dose-escalation of foretinib. Then Phase II will assess the safety and tolerability of foretinib dosed at MTD.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Foretinib	Phase I starting dose 30 mg/day escalated to 45 mg/day; de-escalated to 30 mg/day. MTD for Phase II dose was 30 mg/day,

Timeline

• Start date: 2009-08-12
• Primary completion: 2012-03-07
• Completion: 2015-03-24
• First posted: 2009-06-15
• Last updated: 2017-07-18

Locations

7 sites across 3 countries: Hong Kong, Taiwan, Thailand