Trial intelligence / Profile preview

OSI-774 (Erlotinib) in Hepatocellular or Biliary Carcinoma

NCT00033462Phase 2

Key facts

Status: Completed
Start: Mar 2002
Primary completion: Nov 2006
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: erlotinib
Conditions: hepatocellular carcinoma (HCC)cholangiocarcinoma

Overview

Phase 2, open-label, single-arm trial of erlotinib in hepatocellular carcinoma (HCC) and cholangiocarcinoma, sponsored by National Cancer Institute. Primary endpoint: Proportion of patients who are progression-free at 24 weeks. Started Mar 2002; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Arm I
Patients receive oral erlotinib once daily.

Endpoints

Primary

Proportion of patients who are progression-free at 24 weeks24 weeks

Secondary

Objective Response RateUp to 3 years
Overall SurvivalUp to 3 years
Time to Disease ProgressionUp to 3 years
EGFR Protein Levels
Overall Response Rate in EGFR Positive PatientsUp to 3 years
Toxicity ProfileUp to 3 years

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