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NCT00568308 Clinical Trial

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

Cancer Clinical Trial

— PATHWAY  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00568308
Other study ID # PR88302
Secondary ID
Status Terminated
Phase Phase 3
First received December 4, 2007
Last updated June 13, 2011
Start date December 2007
Est. completion date July 2008

Study information
Verified date June 2011
Source Progen Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationHong Kong: Department of HealthMalaysia: Ministry of HealthThailand: Food and Drug AdministrationVietnam: Ministry of HealthTaiwan: Department of HealthChina: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)Singapore: Health Sciences AuthorityFrance: Ministry of HealthItaly: Ministry of HealthSpain: Ministry of HealthEach Site: Institutional Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 600
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PI-88
160mg subcutaneous injection
• placebo
matched placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Progen Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Hong Kong,  Italy,  Malaysia,  Singapore,  Spain,  Taiwan,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-free Survival End of Study No
Secondary Overall Survival End of study No
Secondary Time to Recurrence End of Study No
Secondary Quality of Life End of Study No
Secondary Safety and Tolerability End of Study Yes
Secondary Compliance End of Study No
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