Liver NeoplasmsNCT00051532
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
A study testing Seocalcitol in people with Liver Neoplasms, run by LEO Pharma at 5 sites in 5 countries.
Trial summary
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Seocalcitol
- How many people
- 700 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 1999to May 2004
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospital in- or out-patients
- Either sex
- Aged 18-75 years
- With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
- Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.
Who cannot join
- Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1
- Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
- A history of renal stone(s)
- A life expectancy of < 3 months
- World Health Organization (WHO) performance status 3 or 4
- Okuda stage III.
Show all 9Show fewer
- Patients with hypercalcemia, or other clinically important laboratory abnormalities
- Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.
- All patients must give their signed informed consent to join the study.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Canada1 site
E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)
Toronto, Alberta, M5G2C4
France1 site
E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)
Metz, F-57038 Metz Cedex
Italy1 site
E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)
Milan, I-20 122
Spain1 site
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
Barcelona, E-08036
United Kingdom1 site
E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Edinburgh, EH39YW
About this study
Official title: Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).
- Conditions
- Liver Neoplasms
- Being tested
- Seocalcitol
- Keywords
- hepatocellular, carcinoma, liver, cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeocalcitolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival, defined as the time from start of treatment to death
Secondary outcomes (14)
HCC-specific survival from start of treatment
Time to response from start of treatment (complete or partial response)
Proportion of patients who achieve partial/complete response
Time to progression measured from start of treatment
Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded
Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed
Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed
Change(s) in tumour size
Change in tumour marker
Number of days of hospitalisation (in-patient care)
Quality of life
Adverse events
Change in laboratory values
Dose of seocalcitol (seocalcitol treated patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2003 (estimated)
- Study startSep 1999
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 700 participants
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hanne Hvidberg, MSc Pharm, PhD, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051532
- Sponsor's protocol ID
- EBC 9801 INT
- Other IDs
- EBC 9801 INT
- Status last verified
- Apr 2005
- First submitted
- 13 Jan 2003
- Last updated
- 25 Feb 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment
- ClinicalTrials.gov ID
- NCT00051532
- Acronym / sponsor ID
- EBC 9801 INT
- Conditions
- Liver Neoplasms
- Keywords
- hepatocellular, carcinoma, liver, cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 700 participants
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Study completion
- May 2004
- First posted
- 14 Jan 2003 (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.
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospital in- or out-patients
- Either sex
- Aged 18-75 years
- With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
- Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.
Key exclusion criteria (9 listed)
- Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1
- Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
- A history of renal stone(s)
- A life expectancy of < 3 months
- World Health Organization (WHO) performance status 3 or 4
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 |
|---|---|---|
| Seocalcitol | Drug | – |
Primary outcome
Overall survival, defined as the time from start of treatment to death
14 secondary outcomes
HCC-specific survival from start of treatment
Time to response from start of treatment (complete or partial response)
Proportion of patients who achieve partial/complete response
Time to progression measured from start of treatment
Duration of complete response in patients showing a complete response, measured from the first date when absence of disease was recorded until the first date of disease progression was recorded
Duration of partial response in patients showing partial response, measured from first date when partial response was recorded until the first date at which disease progression was observed
Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed
Change(s) in tumour size
Change in tumour marker
Number of days of hospitalisation (in-patient care)
Quality of life
Adverse events
Change in laboratory values
Dose of seocalcitol (seocalcitol treated patients)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hanne Hvidberg, MSc Pharm, PhD study director
LEO Pharma
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seocalcitol in people with Liver Neoplasms, run by LEO Pharma at 5 sites in 5 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 5 inclusion and 9 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, France, Italy, Spain, United Kingdom. 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.
Are results available for this study?
The study was stopped early. 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.
What does the primary outcome measure?
Overall survival, defined as the time from start of treatment to death. It is what the study was designed to measure, not a finding.
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 25 Feb 2025.