CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
bavituximab (0.3 mg/kg) and sorafenib +2 moredrug
Likely dose
bavituximab (0.3 mg/kg) and sorafenibfrom 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/NCT01264705
NCT01264705Phase 2Completed
CompareCT.gov

A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma

University of Texas Southwestern Medical Center·interventional·Posted Dec 22, 2010·Updated Nov 12, 2020

In Brief

A Phase 2 clinical trial evaluating bavituximab (0.3 mg/kg) and sorafenib, bavituximab (1.0 mg/kg ) and sorafenib, and 1 other intervention for Hepatocellular Carcinoma and Liver Cancer. Completed, enrolled 47 participants across 1 site.

Detailed Summary

This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma, Liver Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 22, 2010
Enrollment StartJan 1, 2011
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 15.5 years ago

Interventions

bavituximab (0.3 mg/kg) and sorafenibdrug

Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily

bavituximab (1.0 mg/kg ) and sorafenibdrug

Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily

bavituximab (3.0 mg/kg) and sorafenibdrug

Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily