Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
This study has been terminated.
Sponsor:
LEO Pharma
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00051532
First received: January 13, 2003
Last updated: March 5, 2007
Last verified: April 2005
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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
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:
|
Neoplasms Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma Seocalcitol Calcitriol Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamins Micronutrients Growth Substances Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013