NCT00802555

Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)

A Phase 1b Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, single-arm Phase 1b study designed to evaluate safety and tolerability of ARQ 197 in cirrhotic patients with HCC.

Detailed description

Study designed to evaluate safety and tolerability of ARQ 197 in cirrhotic patients with HCC who have received ≤2 prior systemic regimens for HCC, and whose liver disease severity is categorized as Class A and B per Child-Pugh Classification.

Conditions

• Cirrhosis
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	ARQ 197	360 mg administered twice daily until disease progression, unacceptable toxicity, or other discontinuation criterion is met

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-12-05
• Last updated: 2012-07-12

Locations

5 sites across 3 countries: United States, Italy, Spain