Trial intelligence / Profile preview

Seocalcitol in Advanced Hepatocellular Carcinoma

NCT00051532Phase 3

Key facts

Status: Terminated
Start: Sep 1999
Countries: 5
Sponsor: LEO Pharma

Drugs: seocalcitol
Conditions: hepatocellular carcinoma (HCC)

Overview

Phase 3, randomised, double-blind trial in hepatocellular carcinoma (HCC) comparing Seocalcitol Arm with Placebo Arm (2 arms). Primary endpoint: Overall Survival. Started Sep 1999; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Seocalcitol Arm
Patients receive oral seocalcitol (EB 1089) 5ug enteric-coated capsules.
Placebo Arm
Patients receive matching placebo capsules.

Who it enrols

Patients aged 18-75 with histologically verified hepatocellular carcinoma not amenable to curative treatment, classifiable as BCLC stage 0, with measurable disease and a life expectancy of at least 3 months.

Endpoints

Primary

Overall Survival

Secondary

Hepatocellular Carcinoma-specific Survival
Time to Response
Objective Response Rate
Time to Progression
Duration of Complete Response
Duration of Partial Response
Duration of Stable Disease
Change in Tumor Size

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