Study Stopped
Commercial decision to discontinue the study
Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma
PATHWAY
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
1 other identifier
interventional
600
10 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Dec 2007
Shorter than P25 for phase_3 cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJune 15, 2011
June 1, 2011
7 months
December 4, 2007
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival
End of Study
Secondary Outcomes (5)
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
Study Arms (2)
1
PLACEBO COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
United States of America, New York, United States
Unknown Facility
Australia, Australia
Unknown Facility
Canada, Canada
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Italy, Italy
Unknown Facility
Malaysia, Malaysia
Unknown Facility
Singapore, Singapore
Unknown Facility
Spain, Spain
Unknown Facility
Dawan, Taiwan
Unknown Facility
Thailand, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronnie TP Poon, MD
University of Hong Kong, Queen Mary Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 6, 2007
Study Start
December 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 15, 2011
Record last verified: 2011-06