NCT00872014

A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy. Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.

Detailed description

The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC).

Conditions

• Advanced Hepatocellular Carcinoma
• Inoperable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	AMG 386	Two doses of AMG 386 (15 mg/kg) IV QW will be studied
DRUG	AMG 386	Two doses of AMG 386 (10 mg/kg) IV QW will be studied
DRUG	Sorafenib	Sorafenib 400 mg PO BID orally twice daily in an every 4 week dosing schedule for 15mg/kg cohort \& 10mg/kg cohort

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-10-01
• Completion: 2015-06-01
• First posted: 2009-03-30
• Last updated: 2016-04-04