Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Seocalcitol

About this trial

This is an interventional educational/counseling/training trial for Liver Neoplasms focused on measuring hepatocellular, carcinoma, liver, cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)
E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)
E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

Outcomes

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)

Full Information

NCT ID

NCT00051532

First Posted

January 13, 2003

Last Updated

March 5, 2007

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00051532

Brief Title

Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2005

Overall Recruitment Status

Terminated

Study Start Date

September 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

LEO Pharma

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms

Keywords

hepatocellular, carcinoma, liver, cancer

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Not Applicable

Masking

Double

Allocation

Randomized

Enrollment

700 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Seocalcitol

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

HCC-specific survival from start of treatment

Title

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

Title

Proportion of patients who achieve partial/complete response

Title

Time to progression measured from start of treatment

Title

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

Title

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

Title

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

Title

Change(s) in tumour size

Title

Change in tumour marker

Title

Number of days of hospitalisation (in-patient care)

Title

Quality of life

Title

Adverse events

Title

Change in laboratory values

Title

Dose of seocalcitol (seocalcitol treated patients)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanne Hvidberg, MSc Pharm, PhD

Organizational Affiliation

LEO Pharma

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Toronto

State/Province

Alberta

ZIP/Postal Code

M5G2C4

Country

Canada

Facility Name

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

City

Metz

ZIP/Postal Code

F-57038 Metz Cedex

Country

France

Facility Name

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

City

Milano

ZIP/Postal Code

I-20 122

Country

Italy

Facility Name

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

City

Barcelona

ZIP/Postal Code

E-08036

Country

Spain

Facility Name

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

City

Edinburgh

ZIP/Postal Code

EH39YW

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.leo-pharma.com

Description

Click here for more information about this study: Drug Development, Pipeline, Seocalcitol

Liver Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial