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Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
This study has been terminated.
Study NCT00051532   Information provided by LEO Pharma
First Received: January 13, 2003   Last Updated: March 5, 2007   History of Changes

January 13, 2003
March 5, 2007
September 1999
 
Overall survival, defined as the time from start of treatment to death
Same as current
Complete list of historical versions of study NCT00051532 on ClinicalTrials.gov Archive Site
  • 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)
  • 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.
  • No. of days of hospitalisation (in-patient care).
  • Quality of life.
  • Adverse events.
  • Change in laboratory values.
  • Dose of Seocalcitol (Seocalcitol treated patients).
 
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
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

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

 
 
Interventional
Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Efficacy Study
Liver Neoplasms
Drug: Seocalcitol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
700
May 2004
 

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Italy,   Spain,   United Kingdom
 
NCT00051532
 
EBC 9801 INT, EBC 9801 INT
LEO Pharma
 
Study Director: Hanne Hvidberg, MSc Pharm, PhD LEO Pharma
LEO Pharma
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP