Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma (PATHWAY)
|
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 evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00568308 |
|
Recruitment Status
:
Terminated
(Commercial decision to discontinue the study)
First Posted
: December 6, 2007
Last Update Posted
: June 15, 2011
|
Sponsor:
Progen Pharmaceuticals
Information provided by:
Progen Pharmaceuticals
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Liver Cancer Primary Liver Cancer Hepatocellular Carcinoma Hepatoma | Drug: PI-88 Drug: placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| 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 |
| Study Start Date : | December 2007 |
| Actual Primary Completion Date : | July 2008 |
| Actual Study Completion Date : | July 2008 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: 1 |
Drug: placebo
matched placebo
|
| Experimental: 2 |
Drug: PI-88
160mg subcutaneous injection
|
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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | Liz Wilson, Progen Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00568308 History of Changes |
| Other Study ID Numbers: |
PR88302 |
| First Posted: | December 6, 2007 Key Record Dates |
| Last Update Posted: | June 15, 2011 |
| Last Verified: | June 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 |