- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319683
A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
December 12, 2008 updated by: Adherex Technologies, Inc.
A Phase 1/2 Study in Subjects With Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma, Evaluating the Safety, and Anti-Tumor Activity of ADH300004 (Eniluracil) With Escalating Doses of 5 Fluorouracil Administered Orally Once Weekly for 3 Weeks Out of Every 4 (Adherex Protocol Number AHX-03-103)
5-fluorouracil (5-FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD).
ADH300004 blocks DPD.
This study will test the safety and effects of oral ADH300004 14 hours prior to oral 5-FU in subjects with locally advanced, recurrent, or metastatic hepatocellular carcinoma.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore
- Johns Hopkins Singapore International Medical Center
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Chiayi, Taiwan
- Chang Gung memorial hospital
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Kaohsiung, Taiwan
- Chung-Ho Memorial Hospital, Kaohsiung Medical University
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Taipei, Taiwan
- Tri-Service General Hospital
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Taipei, Taiwan
- National Health Research Institute, Ward Veterans General Hospital
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Queens Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent
- In the Phase I portion, Asian subjects that are > or = to 18 years of age
- In the Phase II portion, any subjects that are > or = to 18 years of age
- Non-resectable locally advanced, recurrent, or metastatic hepatocellular carcinoma (HCC) that is either histologically proven or a radiologically documented liver mass with: (alpha-fetoprotein [AFP] > 4,000 ng/mL, hepatitis B surface antigen positive or alpha-fetoprotein [AFP] > 400 ng/mL, hepatitis B surface antigen negative)
- Radiologically documented measurable disease
- Adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
- Willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of ADH300004 in this study
Exclusion Criteria:
- Chemotherapy, radiotherapy, or any other investigational drug within 28 days prior to study entry
- No more than 1 previous treatment with systemic chemotherapy (chemotherapy administered as part of a chemo-embolization procedure is not considered systemic chemotherapy)
- Portal hypertension with bleeding esophageal or gastric varices within the past 3 months
- Ascites that is refractory to conservative management
- Inability to take oral medication
- Active peptic ulcer disease
- Known hypersensitivity to 5-FU or ADH300004
- History of primary brain tumors or brain metastases
- Previous or concurrent malignancy at another site within the last 5 years
- Stroke, major surgery, or other major tissue injury within 30 days before study entry
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacqueline Whang-Peng, MD, National Health Research Institute, Ward Veterans General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 27, 2006
First Submitted That Met QC Criteria
April 27, 2006
First Posted (Estimate)
April 27, 2006
Study Record Updates
Last Update Posted (Estimate)
December 15, 2008
Last Update Submitted That Met QC Criteria
December 12, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Eniluracil
Other Study ID Numbers
- AHX-03-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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