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

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ClinicalTrials.gov Identifier: NCT00568308
Recruitment Status : Terminated (Commercial decision to discontinue the study)
First Posted : December 6, 2007
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Progen Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
Estimated 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 : December 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
matched placebo

Experimental: 2 Drug: PI-88
160mg subcutaneous injection




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

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: End of study ]
  2. Time to Recurrence [ Time Frame: End of Study ]
  3. Quality of Life [ Time Frame: End of Study ]
  4. Safety and Tolerability [ Time Frame: End of Study ]
  5. Compliance [ Time Frame: End of Study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Liz Wilson, Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00568308     History of Changes
Other Study ID Numbers: PR88302
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011

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
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases