CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin +1 moredrug
Likely dose
Sorafenib (BAY43-9006) in combination with doxorubicin; specific dose not stated in available textAI-extracted
Key inclusion· 4
  • ✓Histologically or cytologically documented advanced HCC (unresectable and/or metastatic)
  • ✓At least one measurable tumor lesion by RECIST that has not received prior local therapy
  • ✓Life expectancy of at least 12 weeks
  • ✓ECOG performance status 0, 1, or 2
Key exclusion· 5
  • ✕History of cardiac disease or serious myocardial dysfunction
  • ✕Known CNS tumors including metastatic brain disease
  • ✕Clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • ✕Prior or concurrent cancer distinct in primary site or histology from HCC (with limited exceptions: cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors, or any cancer curatively treated >3 years prior)

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

Search/NCT00108953
NCT00108953Phase 2Completed
CompareCT.gov

A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Bayer·interventional·Posted Apr 22, 2005·Updated Oct 31, 2014

In Brief

A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin and Doxorubicin/Placebo for Carcinoma, Hepatocellular. Completed, enrolled 96 participants across 28 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesArgentina, Canada, Hong Kong, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2005
Enrollment StartApr 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 21.2 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006) plus Doxorubicindrug

Multi kinase inhibitor plus Chemotherapy

Doxorubicin/Placebodrug

Chemotherapy plus Placebo