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

This study has been terminated.
(Commercial decision to discontinue the study)
Sponsor:
Information provided by:
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00568308
First received: December 4, 2007
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Time to Recurrence [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
  • Compliance [ Time Frame: End of Study ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00568308

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

Additional Information:
No publications provided

Responsible Party: Liz Wilson, Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00568308     History of Changes
Other Study ID Numbers: PR88302
Study First Received: December 4, 2007
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Hong Kong: Department of Health
Malaysia: Ministry of Health
Thailand: Food and Drug Administration
Vietnam: Ministry of Health
Taiwan: Department of Health
China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Singapore: Health Sciences Authority
France: Ministry of Health
Italy: Ministry of Health
Spain: Ministry of Health
Each Site: Institutional Ethics Committee

Keywords provided by Progen Pharmaceuticals:
Hepatocellular Carcinoma
PI-88
Phase III
Adjuvant Therapy
Hepatoma
Liver Cancer

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on August 28, 2014