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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:
Progen Pharmaceuticals
Information provided by:
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00568308
First received: December 4, 2007
Last updated: June 13, 2011
Last verified: June 2011
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, 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:
Further study details as provided by Progen Pharmaceuticals:
Primary Outcome Measures:
- Disease-free Survival [ Time Frame: End of Study ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: End of study ]
- Time to Recurrence [ Time Frame: End of Study ]
- Quality of Life [ Time Frame: End of Study ]
- Safety and Tolerability [ Time Frame: End of Study ]
- Compliance [ Time Frame: End of Study ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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:
| 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 |
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 August 17, 2017