MedTrace Logo

Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

NCT01264705 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-11-12

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

bavituximab (0.3 mg/kg) and sorafenib

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

DRUG

bavituximab (1.0 mg/kg ) and sorafenib

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

DRUG

bavituximab (3.0 mg/kg) and sorafenib

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Adam C Yopp, MD · UT Southwestern Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01264705 on ClinicalTrials.gov