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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)
Sponsor:
Information provided by:
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00568308
First received: December 4, 2007
Last updated: June 13, 2011
Last verified: June 2011

December 4, 2007
June 13, 2011
December 2007
July 2008   (final data collection date for primary outcome measure)
Disease-free Survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568308 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cancer
  • Liver Cancer
  • Primary Liver Cancer
  • Hepatocellular Carcinoma
  • Hepatoma
  • Drug: PI-88
    160mg subcutaneous injection
  • Drug: placebo
    matched placebo
  • Placebo Comparator: 1
    Intervention: Drug: placebo
  • Experimental: 2
    Intervention: Drug: PI-88
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Hong Kong,   Italy,   Malaysia,   Singapore,   Spain,   Taiwan,   Thailand
 
NCT00568308
PR88302
Yes
Liz Wilson, Progen Pharmaceuticals
Progen Pharmaceuticals
Not Provided
Principal Investigator: Ronnie TP Poon, MD University of Hong Kong, Queen Mary Hospital
Progen Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP