Hepatocellular CarcinomaPhase 1/2NCT01264705

Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

A Phase 1/2 study testing bavituximab (0.3 mg/kg) and sorafenib, bavituximab (1.0 mg/kg ) and sorafenib and bavituximab (3.0 mg/kg) and sorafenib in people with Hepatocellular Carcinoma and Liver Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma, Liver Cancer
What is being tested?: bavituximab (0.3 mg/kg) and sorafenib, bavituximab (1.0 mg/kg ) and sorafenib and bavituximab (3.0 mg/kg) and sorafenib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Apr 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Locally advanced or metastatic disease.
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.

Show all 17Show fewer

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.
Child-Pugh Score A.
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
Absolute neutrophil count ≥ 1,500 cells/mm3.
Platelet count ≥ 75,000 cells/mm3.
Total bilirubin ≤ 3.0 mg/dl.
Hemoglobin ≥ 8.5 g/dl.
AST and ALT ≤ 5.0 times upper limit of normal.
D-dimer ≤ 3 times upper limit of normal.
INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated.

Who cannot join

History of bleeding diathesis or coagulopathy.
Symptomatic or clinically active brain metastases.
Major surgery within previous 4 weeks.
History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis > 6 months prior is allowed.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

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

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.

Read the detailed description

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: Hepatocellular Carcinoma, Liver Cancer
Being tested: bavituximab (0.3 mg/kg) and sorafenib, bavituximab (1.0 mg/kg ) and sorafenib, bavituximab (3.0 mg/kg) and sorafenib
Keywords: Cirrhosis, GI Cancer, Hepatitis, Oncology
Medical subject headings: Carcinoma, Hepatocellular, Liver Neoplasms, Fibrosis, Gastrointestinal Neoplasms, Hepatitis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01264705
Study group	Role	What they receive
Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Experimental	Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily Receives: Drug: bavituximab (0.3 mg/kg) and sorafenib
Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Experimental	Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily Receives: Drug: bavituximab (1.0 mg/kg ) and sorafenib
Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Experimental	Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily Receives: Drug: bavituximab (3.0 mg/kg) and sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.
Median radiographic time to progression (TTP) was calculated from treatment initiation to first evidence of disease progression or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-progression data was calculated using Greenwood's formula.
Measured: Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months
Number of Patients With Dose Limiting Toxicity
Dose limiting toxicity by serious adverse events by CTCAE version 4.0
Measured: 8 months.

Secondary outcomes (3)

Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater.
Safety was measured by the number of patients with at least one adverse event as assess by NCI Common Terminology criteria for adverse events (CTCAE)
Measured: Up to 3 months of patient enrollment (phase 1)
Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up.
Median months of overall survival was calculated from treatment initiation to death or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for median months of overall survival was calculated using Greenwood's formula.
Measured: Treatment initiation to death or last follow-up, an average 24 months
Median Months of Disease Specific Survival Calculated From Treatment Initiation to Death From Advanced HCC (Hepatocellular Carcinoma) or Last Follow-up.
Median months of disease specific survival was calculated from treatment initiation to first evidence of death from advanced liver cancer or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-disease specific survival data was calculated using Greenwood's formula.
Measured: Treatment initiation to first evidence of death from advanced liver cancer or last follow-up, an average of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Apr 2018

First posted22 Dec 2010 (estimated)
Study startJan 2011
Primary completionApr 2018
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01264705
Sponsor's protocol ID: STU 062010-150
Status last verified: Oct 2020
First submitted: 1 Dec 2010
Last updated: 12 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 31429027

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT01264705
Acronym / sponsor ID: STU 062010-150
Conditions: Hepatocellular Carcinoma, Liver Cancer
Keywords: Cirrhosis, GI Cancer, Hepatitis, Oncology
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: Jan 2011
Primary completion: Apr 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 22 Dec 2010 (estimated)
Results: Posted 12 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Experimental	Drug: bavituximab (0.3 mg/kg) and sorafenibCohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Experimental	Drug: bavituximab (1.0 mg/kg ) and sorafenibCohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Experimental	Drug: bavituximab (3.0 mg/kg) and sorafenibCohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
Locally advanced or metastatic disease.
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.
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.
Child-Pugh Score A.

Key exclusion criteria (5 listed)

History of bleeding diathesis or coagulopathy.
Symptomatic or clinically active brain metastases.
Major surgery within previous 4 weeks.
History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis > 6 months prior is allowed.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bavituximab (0.3 mg/kg) and sorafenibBavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Drug	Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
bavituximab (1.0 mg/kg ) and sorafenibBavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Drug	Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
bavituximab (3.0 mg/kg) and sorafenibBavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Drug	Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily

Primary outcome

Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.
Time frame: Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months
Median radiographic time to progression (TTP) was calculated from treatment initiation to first evidence of disease progression or last follow-up by using the Kaplan-Meier method. The 95% confidence intervals (CIs) for time-to-progression data was calculated using Greenwood's formula.
Number of Patients With Dose Limiting Toxicity
Time frame: 8 months.
Dose limiting toxicity by serious adverse events by CTCAE version 4.0

3 secondary outcomes

Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater.
Time frame: Up to 3 months of patient enrollment (phase 1)
Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up.
Time frame: Treatment initiation to death or last follow-up, an average 24 months
Median Months of Disease Specific Survival Calculated From Treatment Initiation to Death From Advanced HCC (Hepatocellular Carcinoma) or Last Follow-up.
Time frame: Treatment initiation to first evidence of death from advanced liver cancer or last follow-up, an average of 12 months

Results and safety

Results posted to the registry on 12 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily	3	3
Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily	3	3
Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily	41	41

Primary outcome: Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.

Time frame: Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months. Median (95% Confidence Interval). Unit: months

Measure	Cohort 1 n = 0	Cohort 2 n = 0	Cohort 3 n = 38
Value	–	–	6.7 (4.1 to 16.9)

Population analysed: Cohort 1 and 2 were part of phase 1 study and at the phase 1 study this outcome was not collected. The 3 participants who received dose Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily were part of phase 1 and hence they were not part of phase 2 . Hence their data were not analyzed here.

Primary outcome: Number of Patients With Dose Limiting Toxicity

Time frame: 8 months.. Number. Unit: participants

Measure	Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily n = 3	Bavituximab: 1.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily n = 3	Bavituximab: 3.0 mg/kg Weekly Sorafenib: 400mg PO Twice Daily n = 3
Value	0	0	0

Population analysed: This outcome was for phase 1 only

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 2	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 3	0 of 41 (0%)	12 of 41 (29.3%)	38 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31429027Mokdad 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.

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam C Yopp, MD principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up. (time frame: Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01264705, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.