Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00051532
• Date of registration: 13/01/2003
• Prospective Registration: No
• Primary sponsor: LEO Pharma
• Public title: Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
• Scientific 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
• Date of first enrolment: September 1999
• Target sample size: 700
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00051532
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
• Phase: N/A

Countries of recruitment

Canada, France, Italy, Spain, United Kingdom

Contacts

• Name: Hanne Hvidberg, MSc Pharm, PhD
• Affiliation: LEO Pharma

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Neoplasms

Intervention(s)

Drug: Seocalcitol

Primary Outcome(s)

Overall survival, defined as the time from start of treatment to death

Secondary Outcome(s)

Change in laboratory values

Proportion of patients who achieve partial/complete response

Adverse events

Duration of stable disease measured from start of treatment until the first date where either progression or partial/complete response was observed

Dose of seocalcitol (seocalcitol treated patients)

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

Change in tumour marker

Time to progression measured from start of treatment

Change(s) in tumour size

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

Time to response from start of treatment (complete or partial response)

Number of days of hospitalisation (in-patient care)

Quality of life

HCC-specific survival from start of treatment

Secondary ID(s)

EBC 9801 INT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors