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Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

NCT ID: NCT01264705

Last Updated: 2020-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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The investigators are looking for men or women aged 18 years or older with hepatocellular carcinoma not suitable for surgical resection or hepatic transplantation. Prior locoregional therapy including but not limited to transarterial chemoembolization (TACE), radiofrequency ablation (RFA) or ethanol injection is allowed as long as the treatment was 4 weeks previous. Patients must be Child-Pugh A with no previous treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors.

Conditions

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Hepatocellular Carcinoma Liver Cancer

Keywords

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Cirrhosis GI Cancer Hepatitis Oncology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily

Group Type EXPERIMENTAL

bavituximab (0.3 mg/kg) and sorafenib

Intervention Type DRUG

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

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

Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily

Group Type EXPERIMENTAL

bavituximab (1.0 mg/kg ) and sorafenib

Intervention Type DRUG

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

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

Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily

Group Type EXPERIMENTAL

bavituximab (3.0 mg/kg) and sorafenib

Intervention Type DRUG

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

Interventions

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bavituximab (0.3 mg/kg) and sorafenib

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

Intervention Type DRUG

bavituximab (1.0 mg/kg ) and sorafenib

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

Intervention Type DRUG

bavituximab (3.0 mg/kg) and sorafenib

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:

* Histologically confirmed.
* MRI or CT consistent with liver cirrhosis and at least one solid liver lesion \>2 cm with early enhancement and delayed enhancement washout regardless of AFP.
* AFP \>400 ng/ml and evidence of at least one solid liver lesion \>2 cm regardless of specific imaging characteristics on CT or MRI.
2. Locally advanced or metastatic disease.
3. Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons.
4. Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography.
5. Child-Pugh Score A.
6. Age ≥ 18 years.
7. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
8. Absolute neutrophil count ≥ 1,500 cells/mm3.
9. Platelet count ≥ 75,000 cells/mm3.
10. Total bilirubin ≤ 3.0 mg/dl.
11. Hemoglobin ≥ 8.5 g/dl.
12. AST and ALT ≤ 5.0 times upper limit of normal.
13. D-dimer ≤ 3 times upper limit of normal.
14. INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated.

Exclusion Criteria

1. History of bleeding diathesis or coagulopathy.
2. Symptomatic or clinically active brain metastases.
3. Major surgery within previous 4 weeks.
4. History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis \> 6 months prior is allowed.
5. Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed \> 6 months ago and there is documented recurrence of hepatocellular carcinoma.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adam Yopp

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam C Yopp, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Mokdad AA, Zhu H, Beg MS, Arriaga Y, Dowell JE, Singal AG, Yopp AC. Efficacy and Safety of Bavituximab in Combination with Sorafenib in Advanced Hepatocellular Carcinoma: A Single-Arm, Open-Label, Phase II Clinical Trial. Target Oncol. 2019 Oct;14(5):541-550. doi: 10.1007/s11523-019-00663-3.

Reference Type DERIVED
PMID: 31429027 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STU 062010-150

Identifier Type: -

Identifier Source: org_study_id