At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
Sorafenib +1 moredrug
Likely dose
Sorafenib 200 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.
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating Sorafenib for Hepatocellular Carcinoma. Completed, enrolled 102 participants across 24 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesBelgium, Italy, Spain, Ukraine, United Kingdom, United States
CollaboratorsPharmaBio Development Inc.
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartJul 2011
Primary CompletionJun 2015
TodayJul 2026
First PostedJan 6, 2011
Enrollment StartJul 19, 2011
Primary CompletionJun 23, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.5 years ago
Interventions
Sorafenibdrug
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
Sorafenibdrug
E7050 given orally at 200, 300 or 400 mg once daily. Sorafenib given orally, 400 mg twice daily.