NCT00568308

Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma

A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, International, Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Progen Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Detailed description

Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Conditions

• Cancer
• Liver Cancer
• Primary Liver Cancer
• Hepatocellular Carcinoma
• Hepatoma

Interventions

Type	Name	Description
DRUG	PI-88	160mg subcutaneous injection
DRUG	placebo	matched placebo

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-12-06
• Last updated: 2011-06-15

Locations

10 sites across 10 countries: United States, Australia, Canada, Hong Kong, Italy, Malaysia, Singapore, Spain, Taiwan, Thailand