Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

February 21, 2025 updated by: LEO Pharma

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]).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

700

Phase

  • Not Applicable

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

  • Canada
    • Alberta
      • Toronto, Alberta, Canada, M5G2C4
        • E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)
  • France
      • Metz, France, F-57038 Metz Cedex
        • E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)
  • Italy
      • Milano, Italy, I-20 122
        • E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)
  • Spain
      • Barcelona, Spain, E-08036
        • E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
  • United Kingdom
      • Edinburgh, United Kingdom, EH39YW
        • E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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: Other
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival, defined as the time from start of treatment to death

Secondary Outcome Measures

Outcome Measure
Adverse events
Quality of life
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)
Change in laboratory values
Dose of seocalcitol (seocalcitol treated patients)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Study Director: Hanne Hvidberg, MSc Pharm, PhD, LEO Pharma

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 Major Dates

Study Start

September 1, 1999

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

January 13, 2003

First Submitted That Met QC Criteria

January 13, 2003

First Posted (Estimated)

January 14, 2003

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

April 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBC 9801 INT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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