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 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:
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 |
| 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
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:
No publications provided
| 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 |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 16, 2013