Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00568308




Registration number
NCT00568308
Ethics application status
Date submitted
4/12/2007
Date registered
6/12/2007
Date last updated
15/06/2011

Titles & IDs
Public title
Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma
Scientific 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
Secondary ID [1] 0 0
PR88302
Universal Trial Number (UTN)
Trial acronym
PATHWAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Liver Cancer 0 0
Primary Liver Cancer 0 0
Hepatocellular Carcinoma 0 0
Hepatoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PI-88
Treatment: Drugs - placebo

Placebo Comparator: 1 -

Experimental: 2 -


Treatment: Drugs: PI-88
160mg subcutaneous injection

Treatment: Drugs: placebo
matched placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival
Timepoint [1] 0 0
End of Study
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
End of study
Secondary outcome [2] 0 0
Time to Recurrence
Timepoint [2] 0 0
End of Study
Secondary outcome [3] 0 0
Quality of Life
Timepoint [3] 0 0
End of Study
Secondary outcome [4] 0 0
Safety and Tolerability
Timepoint [4] 0 0
End of Study
Secondary outcome [5] 0 0
Compliance
Timepoint [5] 0 0
End of Study

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Australia
Recruitment postcode(s) [1] 0 0
- Australia
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Canada
State/province [2] 0 0
Canada
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Hong Kong
Country [4] 0 0
Italy
State/province [4] 0 0
Italy
Country [5] 0 0
Malaysia
State/province [5] 0 0
Malaysia
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore
Country [7] 0 0
Spain
State/province [7] 0 0
Spain
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taiwan
Country [9] 0 0
Thailand
State/province [9] 0 0
Thailand

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Progen Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00568308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ronnie TP Poon, MD
Address 0 0
University of Hong Kong, Queen Mary Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00568308