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

Purpose

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	Intervention	Phase
Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma	Drug: PI-88 Drug: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Liver Cancer

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

Further study details as provided by Progen Pharmaceuticals:

Primary Outcome Measures:

Disease-free Survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	600
Study Start Date:	December 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Drug: placebo matched placebo
Experimental: 2	Drug: PI-88 160mg subcutaneous injection

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Progen Pharmaceuticals Website This link exits the ClinicalTrials.gov site


Responsible Party:	Liz Wilson, Progen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00568308 History of Changes
Other Study ID Numbers:	PR88302
Study First Received:	December 4, 2007
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration Hong Kong: Department of Health Malaysia: Ministry of Health Thailand: Food and Drug Administration Vietnam: Ministry of Health Taiwan: Department of Health China: Food and Drug Administration South Korea: Korea Food and Drug Administration (KFDA) Singapore: Health Sciences Authority France: Ministry of Health Italy: Ministry of Health Spain: Ministry of Health Each Site: Institutional Ethics Committee

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

ClinicalTrials.gov processed this record on September 28, 2016

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