Hepatocellular CarcinomaPhase 1/2NCT00319683
A Study of ADH300004 and 5-Fluorouracil in Locally Advanced, Recurrent, or Metastatic Hepatocellular Carcinoma
A Phase 1/2 study testing ADH300004 in people with Hepatocellular Carcinoma, run by Adherex Technologies, Inc. at 7 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ADH300004
- How many people
- Not given
- Where
- 7 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Taiwan5 sites
Chang Gung Memorial Hospital
Chiayi City
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City
National Health Research Institute, Ward Veterans General Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Singapore1 site
Johns Hopkins Singapore International Medical Center
Singapore
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ADH300004
- Keywords
- Cancer, Tumors, Neoplasms, Anticarcinogenic Agents, Antineoplastic Agents, Dihydrouracil Dehydrogenase (NADP)
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADH300004Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Adherex Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacqueline Whang-Peng, MD, Principal investigator, National Health Research Institute, Ward Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319683
- Sponsor's protocol ID
- AHX-03-103
- Status last verified
- Dec 2008
- First submitted
- 27 Apr 2006
- Last updated
- 15 Dec 2008
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00319683
- Acronym / sponsor ID
- AHX-03-103
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Cancer, Tumors, Neoplasms, Anticarcinogenic Agents, Antineoplastic Agents, Dihydrouracil Dehydrogenase (NADP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds
- Lead sponsor
- Adherex Technologies, Inc.Industry (pharma, biotech, devices)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADH300004 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2008.
- Adherex Technologies Inc. Corporate HomepageLink provided by the sponsor.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Whang-Peng, MD principal investigator
National Health Research Institute, Ward Veterans General Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADH300004 in people with Hepatocellular Carcinoma, run by Adherex Technologies, Inc. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan, United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funds). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2008.