Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma - Full Text View

Sponsor:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00051532

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:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Efficacy Study
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:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: EB 1089

U.S. FDA Resources

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

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:

Click here for more information about this study: Drug Development, Pipeline, Seocalcitol This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by LEO Pharma:

hepatocellular
carcinoma
liver
cancer

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
Seocalcitol
Immunosuppressive Agents

Pharmacologic Actions
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009