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Study of Sorafenib and Infusional 5-Fluorouracil in Advanced Hepatocellular Carcinoma (HCC)

NCT00619541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2009-02-26

No results posted yet for this study

Summary

The purpose of this study is to use Sorafenib + 5-FU to evaluate activity, efficacy, safety, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with advanced hepatocellular carcinoma (HCC).

Conditions

Interventions

DRUG

Infusional 5-Fluorouracil

5-FU 3000 mg/sqm 48 hours continuous infusion every 14 days. 5-FU will be administered for a maximum of 12 cycles.

DRUG

Sorafenib (Bay 43-9006)

Sorafenib 400 mg bid orally continuously. Sorafenib will be administered from the start of treatment in combination with 5-FU until progression of disease.

Sponsors & Collaborators

  • Italian Trial in Medical Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-11-30
Completion
2009-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619541 on ClinicalTrials.gov