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Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

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: NCT00051532
Recruitment Status : Terminated
First Posted : January 14, 2003
Last Update Posted : March 6, 2007
Information provided by:
LEO Pharma

Brief Summary:
The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).

Condition or disease Intervention/treatment
Liver Neoplasms Drug: Seocalcitol

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Educational/Counseling/Training
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
Study Start Date : September 1999
Estimated Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Overall survival, defined as the time from start of treatment to death

Secondary Outcome Measures :
  1. HCC-specific survival from start of treatment
  2. Time to response from start of treatment (complete or partial response)
  3. Proportion of patients who achieve partial/complete response
  4. Time to progression measured from start of treatment
  5. 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
  6. 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
  7. Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed
  8. Change(s) in tumour size
  9. Change in tumour marker
  10. Number of days of hospitalisation (in-patient care)
  11. Quality of life
  12. Adverse events
  13. Change in laboratory values
  14. Dose of seocalcitol (seocalcitol treated patients)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00051532

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00051532     History of Changes
Other Study ID Numbers: EBC 9801 INT
First Posted: January 14, 2003    Key Record Dates
Last Update Posted: March 6, 2007
Last Verified: April 2005

Keywords provided by LEO Pharma:

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents