Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

This study has been terminated.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00051532
First received: January 13, 2003
Last updated: March 5, 2007
Last verified: April 2005
  Purpose

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


Condition Intervention
Liver Neoplasms
Drug: Seocalcitol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 700
Study Start Date: September 1999
Estimated Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051532

Locations
Canada, Alberta
E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)
Toronto, Alberta, Canada, M5G2C4
France
E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)
Metz, France, F-57038 Metz Cedex
Italy
E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)
Milano, Italy, I-20 122
Spain
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
Investigators
Study Director: Hanne Hvidberg, MSc Pharm, PhD LEO Pharma
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00051532     History of Changes
Other Study ID Numbers: EBC 9801 INT, EBC 9801 INT
Study First Received: January 13, 2003
Last Updated: March 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by LEO Pharma:
hepatocellular
carcinoma
liver
cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Seocalcitol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014