CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006)drug
Likely dose
Sorafenib 400 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
  • ✓Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
  • ✓At least 1 bidimensionally measurable lesion of at least 2 cm by CT or MRI
  • ✓At least one of: AFP > ULN, hepatitis C antibody positive, or hepatitis B surface antigen positive
Key exclusion· 2
  • ✕Fibrolamellar disease or mixed histology
  • ✕Metastatic brain or meningeal tumors

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00044512
NCT00044512Phase 2Completed
CompareCT.gov

A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

Bayer·interventional·Posted Sep 4, 2002·Updated Apr 16, 2014

In Brief

A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) for Carcinoma, Hepatocellular. Completed, enrolled 137 participants across 23 sites in 5 countries.

Detailed Summary

Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesBelgium, France, Israel, Italy, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 4, 2002
Enrollment StartAug 1, 2002
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 23.8 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)