Trial Outcomes & Findings for Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer (NCT NCT01264705)

Last Updated: 2020-11-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months

Results posted on

2020-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	3	3	41
Overall Study COMPLETED	3	3	41
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bavituximab:0.3 mg/kg Weekly Sorafenib: 400mg PO Twice Daily n=3 Participants Cohort 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 n=3 Participants Cohort 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 n=41 Participants Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	33 Participants n=5 Participants	37 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	34 Participants n=5 Participants	38 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Treatment initiation to first evidence of disease progression or last follow-up, an average of 24 months

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 2 Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 3 n=38 Participants Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.	—	—	6.7 months Interval 4.1 to 16.9

PRIMARY outcome

Timeframe: 8 months.

Population: This outcome was for phase 1 only

Dose limiting toxicity by serious adverse events by CTCAE version 4.0

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 2 n=3 Participants Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 3 n=3 Participants Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Number of Patients With Dose Limiting Toxicity	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 3 months of patient enrollment (phase 1)

Population: This outcome measure was only analyzed for phase 1

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)

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 2 n=3 Participants Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 3 n=3 Participants Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater.	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Treatment initiation to death or last follow-up, an average 24 months

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 2 Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 3 n=38 Participants Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up.	—	—	6.1 months Interval 4.9 to 8.1

SECONDARY outcome

Timeframe: Treatment initiation to first evidence of death from advanced liver cancer or last follow-up, an average of 12 months

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 2 Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 3 n=38 Participants Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Median Months of Disease Specific Survival Calculated From Treatment Initiation to Death From Advanced HCC (Hepatocellular Carcinoma) or Last Follow-up.	—	—	8.6 months Interval 6.2 to 13.5

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 12 other events

Deaths: 38 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Adam Yopp, MD

UT Southwestern Medical Center

Phone: 214-648-5870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 n=3 participants at risk Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 2 n=3 participants at risk Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily	Cohort 3 n=41 participants at risk Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Gastrointestinal disorders Diarrhea	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	29.3% 12/41 • Number of events 12 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
General disorders fatigue	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	24.4% 10/41 • Number of events 10 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Metabolism and nutrition disorders anorexia	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	22.0% 9/41 • Number of events 9 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Gastrointestinal disorders abdominal cramping	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	17.1% 7/41 • Number of events 7 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Cardiac disorders hypertension	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	12.2% 5/41 • Number of events 5 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Gastrointestinal disorders vomiting	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	9.8% 4/41 • Number of events 4 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Skin and subcutaneous tissue disorders Hand /foot syndrome	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	9.8% 4/41 • Number of events 4 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
General disorders nausea	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	7.3% 3/41 • Number of events 3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Gastrointestinal disorders Gerd	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	4.9% 2/41 • Number of events 2 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Gastrointestinal disorders Upper gastrointestinal bleeding	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	2.4% 1/41 • Number of events 1 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Immune system disorders stomstitis	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	4.9% 2/41 • Number of events 2 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Gastrointestinal disorders dysphagia	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	2.4% 1/41 • Number of events 1 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
General disorders infusion reaction	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	2.4% 1/41 • Number of events 1 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
General disorders hiccoughs	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	2.4% 1/41 • Number of events 1 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)
Blood and lymphatic system disorders Deep Vein Thrombosis	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	0.00% 0/3 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)	2.4% 1/41 • Number of events 1 • SAEs and Other AEs were monitored up to 8 months (Phase 1) SAEs and Other AEs were monitored up to 2 years (Phase 2)