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

Sponsor

Progen Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00568308

Collaborator

(none)

600

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma	Drug: PI-88 Drug: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: placebo matched placebo
Experimental: 2	Drug: PI-88 160mg subcutaneous injection

Arm

Intervention/Treatment

Placebo Comparator: 1

Drug: placebo

matched placebo

Experimental: 2

Drug: PI-88

160mg subcutaneous injection

Outcome Measures

Primary Outcome Measures

Disease-free Survival [End of Study]

Secondary Outcome Measures

Overall Survival [End of study]
Time to Recurrence [End of Study]
Quality of Life [End of Study]
Safety and Tolerability [End of Study]
Compliance [End of Study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	United States of America	New York	United States
2	Australia		Australia
3	Canada		Canada
4	Hong Kong		Hong Kong
5	Italy		Italy
6	Malaysia		Malaysia
7	Singapore		Singapore
8	Spain		Spain
9	Taiwan		Taiwan
10	Thailand		Thailand