Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

NCT ID: NCT00051532

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-05-31

Brief Summary

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

Detailed Description

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Conditions

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Liver Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Interventions

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Seocalcitol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Hanne Hvidberg, MSc Pharm, PhD

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)

Toronto, Alberta, Canada

Site Status

E.g. Notre-Dame de Bon Secours, Service d“Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)

Metz, , France

Site Status

E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)

Milan, , Italy

Site Status

E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)

Barcelona, , Spain

Site Status

E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

Edinburgh, , United Kingdom

Site Status

Countries

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Canada France Italy Spain United Kingdom

Related Links

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https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

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EBC 9801 INT

Identifier Type: -

Identifier Source: secondary_id

EBC 9801 INT

Identifier Type: -

Identifier Source: org_study_id

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