| 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 |
| |
| |
| |
| 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 |