Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

NCT00051532 | Terminated

• 1 other identifier: EBC 9801 INT
• Study Type: interventional
• Target: 700
• Locations: 5 countries
• Sites: 5

Brief Summary

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

Conditions

Liver Neoplasms

Keywords

hepatocellular; carcinoma; liver; cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Seocalcitol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (5)

E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)

Toronto, Alberta, M5G2C4, Canada

Location

E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)

Metz, F-57038 Metz Cedex, France

Location

E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)

Milan, I-20 122, Italy

Location

E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)

Barcelona, E-08036, Spain

Location

E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

Edinburgh, EH39YW, United Kingdom

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma; Neoplasms

Interventions

seocalcitol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Hanne Hvidberg, MSc Pharm, PhD

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: OTHER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2003
• First Posted: January 14, 2003
• Study Start: September 1, 1999
• Study Completion: May 1, 2004
• Last Updated: February 25, 2025

Record last verified: 2005-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); CA (1); FR (1); GB (1); ES (1)