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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


N/A
18 Years
75 Years
Not Enrolling
Both
Liver Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

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

Principal Investigator

Hanne Hvidberg, MSc Pharm, PhD

Investigator Role:

Study Director

Investigator Affiliation:

LEO Pharma

Authority:

United States: Food and Drug Administration

Study ID:

EBC 9801 INT

NCT ID:

NCT00051532

Start Date:

September 1999

Completion Date:

May 2004

Related Keywords:

  • Liver Neoplasms
  • hepatocellular
  • carcinoma
  • liver
  • cancer
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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