Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

Liver Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00051532
• Other study ID #: EBC 9801 INT
• Secondary ID: EBC 9801 INT
• Status: Terminated
• Phase: N/A
• First received: January 13, 2003
• Last updated: March 5, 2007
• Start date: September 1999
• Est. completion date: May 2004

Study information

• Verified date: April 2005
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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]).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 700
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Drug:
• Seocalcitol

Locations

Country	Name	City	State
Canada	E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)	Toronto	Alberta
France	E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)	Metz
Italy	E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)	Milano
Spain	E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)	Barcelona
United Kingdom	E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival, defined as the time from start of treatment to death
Secondary	HCC-specific survival from start of treatment
Secondary	Time to response from start of treatment (complete or partial response)
Secondary	Proportion of patients who achieve partial/complete response
Secondary	Time to progression measured from start of treatment
Secondary	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
Secondary	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
Secondary	Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed
Secondary	Change(s) in tumour size
Secondary	Change in tumour marker
Secondary	Number of days of hospitalisation (in-patient care)
Secondary	Quality of life
Secondary	Adverse events
Secondary	Change in laboratory values
Secondary	Dose of seocalcitol (seocalcitol treated patients)

External Links

•   Click here for more information about this study: Drug Development, Pipeline, Seocalcitol