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

This study has been terminated.
(Commercial decision to discontinue the study)
Information provided by:
Progen Pharmaceuticals Identifier:
First received: December 4, 2007
Last updated: June 13, 2011
Last verified: June 2011
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 Intervention Phase
Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma Drug: PI-88 Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:
  • Disease-free Survival [ Time Frame: End of Study ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: End of study ]
  • Time to Recurrence [ Time Frame: End of Study ]
  • Quality of Life [ Time Frame: End of Study ]
  • Safety and Tolerability [ Time Frame: End of Study ]
  • Compliance [ Time Frame: End of Study ]

Estimated Enrollment: 600
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
matched placebo
Experimental: 2 Drug: PI-88
160mg subcutaneous injection

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00568308

United States, New York
United States of America, New York, United States
Australia, Australia
Canada, Canada
Hong Kong
Hong Kong, Hong Kong
Italy, Italy
Malaysia, Malaysia
Singapore, Singapore
Spain, Spain
Taiwan, Taiwan
Thailand, Thailand
Sponsors and Collaborators
Progen Pharmaceuticals
Principal Investigator: Ronnie TP Poon, MD University of Hong Kong, Queen Mary Hospital
  More Information

Additional Information:
Responsible Party: Liz Wilson, Progen Pharmaceuticals Identifier: NCT00568308     History of Changes
Other Study ID Numbers: PR88302
Study First Received: December 4, 2007
Last Updated: June 13, 2011

Keywords provided by Progen Pharmaceuticals:
Hepatocellular Carcinoma
Phase III
Adjuvant Therapy
Liver Cancer

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on September 21, 2017