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

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Progen Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomisation.

• ECOG performance status 0 to 2

• Child Pugh classification A or B

Key Exclusion Criteria:

• Any evidence of tumour metastasis or co-existing malignant disease

• Any prior recurrence of HCC or any liver resection prior to the most recent procedure

• History of prior HCC therapy