CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 732 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +2 moredrug
Likely dose
Sorafenib (Nexavar, BAY43-9006) 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00901901
NCT00901901Phase 3Completed
CompareCT.gov

A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

Bayer·interventional·Posted May 14, 2009·Updated May 30, 2019

In Brief

A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006), Erlotinib (Tarceva), and 1 other intervention for Carcinoma, Hepatocellular. Completed, enrolled 732 participants across 127 sites in 26 countries.

Detailed Summary

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, New Zealand, Peru, Poland, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2009
Enrollment StartMay 21, 2009
Primary CompletionApr 17, 2012
Study CompletionMay 23, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.1 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

Sorafenib 400 mg twice daily

Erlotinib (Tarceva)drug

Erlotinib 150 mg once daily

Placebodrug

Matching erlotinib placebo 150 mg once daily