Trial Outcomes & Findings for A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma (NCT NCT02460991)

NCT ID: NCT02460991

Last Updated: 2021-02-12

Results Overview

Overall survival in HCC subjects with minimum follow-up of subjects to at least one year

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 2 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2021-02-12

Participant Flow

Participant milestones

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved.	Sorafenib 200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Overall Study STARTED	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved.	Sorafenib 200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

A Study of ONCO-DOX in Locally Advanced Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved	Sorafenib n=2 Participants 200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants
Age	—	63 years n=7 Participants	63 years n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The planned analyses were not performed due to early termination.

Overall survival in HCC subjects with minimum follow-up of subjects to at least one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: The planned analyses were not performed due to early termination.

Time to progression (TTP) determined by radiological assessment using mRECIST criteria

Outcome measures

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.	Sorafenib n=2 Participants 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Time to Progression	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: The planned analyses were not performed due to early termination.

Time to Extrahepatic Spread for each subject

Outcome measures

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.	Sorafenib n=2 Participants 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Time to Extrahepatic Spread	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: The planned analyses were not performed due to early termination.

Proportion Progression-Free (PPF) at one year

Outcome measures

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.	Sorafenib n=2 Participants 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Proportion Progression Free	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

Population: Study was terminated early. Adverse events were captured through the end of the study.

The frequency of treatment emergent adverse events at 30 day, 3, 6, 9, 12, 18, and 24-months following the initial treatment. The proportions of patients in each arm experiencing treatment emergent adverse events will be presented descriptively with the number experiencing the event, the number evaluated, the percentage, and the exact two-sided 95% confidence interval.

Outcome measures

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments can be repeated every 4-8 weeks until complete tumor response is achieved.	Sorafenib n=2 Participants 200 mg Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Frequency of Treatment Emergent Adverse Events	—	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

The proportion of patients in each group that achieve complete response (CR), partial response (PR), and stable disease (SD) will be presented and compared across treatment groups.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

FACT-Hep quality of life instrument validated in patients with Hepatic cancer.

Outcome measures

Outcome data not reported

Adverse Events

DEB-TACE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sorafenib

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved	Sorafenib n=2 participants at risk 200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
Vascular disorders Hypertensive Emergency	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.

Other adverse events

Measure	DEB-TACE ONCO-DOX (Doxorubicin loaded Microspheres) up to 150 mg per treatment; treatments could be repeated every 4-8 weeks until complete tumor response was achieved	Sorafenib n=2 participants at risk 200 mg of Sorafenib twice daily; continue until unacceptable toxicity or unequivocal tumor progression
General disorders Non-cardiac chest pain	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.
Skin and subcutaneous tissue disorders Desquamation of bottom of feet	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.
General disorders Fatigue	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.
Gastrointestinal disorders Internal Hemorroids	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.
Investigations Weight Loss	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Metastasis	— 0/0 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.	50.0% 1/2 • Number of events 1 • 2 months Only two subjects were randomized prior to the suspension of the study and both were randomized to the Sorafenib arm. No subjects were randomized to DEB-TACE.

Additional Information

Kristi Winterfeldt

Boston Scientific

Phone: 763-494-1165

Email: kristi.winterfeldt@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place