Trial Outcomes & Findings for Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy (NCT NCT02694562)
NCT ID: NCT02694562
Last Updated: 2019-02-15
Results Overview
Freedom from Serious Adverse Events reports the number of participants that did not have a serious adverse event reported within 30 days of treatment that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defects.
COMPLETED
NA
18 participants
30 days
2019-02-15
Participant Flow
Twenty MIRACLE III subjects were consented. Of these 20, eighteen (18) were enrolled and treated in the trial. Two subjects were not enrolled as they did not meet I/E criteria. These two subjects have been reported as screen failures.
Participant milestones
| Measure |
40um Embozene TANDEM Microspheres
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
40um Embozene TANDEM Microspheres
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Screen Failure
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy
Baseline characteristics by cohort
| Measure |
40um Embozene TANDEM Microspheres
n=18 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
ECOG Score 0
|
18 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
ECOG Score 1
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
ECOG Score 2
|
0 Participants
n=5 Participants
|
|
Classification of Malignant Tumours (TNM) Stage
TNM Stage I
|
0 Participants
n=5 Participants
|
|
Classification of Malignant Tumours (TNM) Stage
TNM Stage II
|
0 Participants
n=5 Participants
|
|
Classification of Malignant Tumours (TNM) Stage
TNM Stage III
|
0 Participants
n=5 Participants
|
|
Classification of Malignant Tumours (TNM) Stage
TNM Stage IV
|
18 Participants
n=5 Participants
|
|
Child Pugh
Child Pugh - A
|
17 Participants
n=5 Participants
|
|
Child Pugh
Child Pugh - B7
|
0 Participants
n=5 Participants
|
|
Child Pugh
Not Available
|
1 Participants
n=5 Participants
|
|
History of Radiotherapy
|
2 Participants
n=5 Participants
|
|
History of Surgical Therapy
|
16 Participants
n=5 Participants
|
|
History of Systemic Therapy
|
18 Participants
n=5 Participants
|
|
Previous Lines of Chemotherapy
Participants with 1 Previous Line of Chemotherapy
|
0 Participants
n=5 Participants
|
|
Previous Lines of Chemotherapy
Participants with 2 Previous Lines of Chemotherapy
|
2 Participants
n=5 Participants
|
|
Previous Lines of Chemotherapy
Participants with 3 Previous Lines of Chemotherapy
|
5 Participants
n=5 Participants
|
|
Previous Lines of Chemotherapy
Participants with 4 Previous Lines of Chemotherapy
|
5 Participants
n=5 Participants
|
|
Previous Lines of Chemotherapy
Participants with 5 Previous Lines of Chemotherapy
|
5 Participants
n=5 Participants
|
|
Previous Lines of Chemotherapy
Participants with 6 Previous Lines of Chemotherapy
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysFreedom from Serious Adverse Events reports the number of participants that did not have a serious adverse event reported within 30 days of treatment that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defects.
Outcome measures
| Measure |
40um Embozene TANDEM Microspheres
n=18 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Freedom From Serious Adverse Events Rate
|
18 Participants
|
PRIMARY outcome
Timeframe: 3 months post procedurePopulation: All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.
Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).
Outcome measures
| Measure |
40um Embozene TANDEM Microspheres
n=17 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Local Tumor Control
|
15 Participants
|
PRIMARY outcome
Timeframe: 6 months post procedurePopulation: All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.
Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).
Outcome measures
| Measure |
40um Embozene TANDEM Microspheres
n=17 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Local Tumor Control
|
7 Participants
|
PRIMARY outcome
Timeframe: 12 months post procedurePopulation: All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.
Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).
Outcome measures
| Measure |
40um Embozene TANDEM Microspheres
n=17 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Local Tumor Control
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 months post procedureNumber of participants that were alive 12 months after their first study treatment.
Outcome measures
| Measure |
40um Embozene TANDEM Microspheres
n=18 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Survival Rate
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post procedurePopulation: Two participants that did not have disease progression reported during the trial are not included in this analysis. One subject underwent liver resection surgery after their third study treatment and another subject's tumor response was reported as stable disease prior to being lost to follow up after their third study treatment.
Time to Tumor Progression is defined as the time from the date of first study treatment to the day of documented disease progression or death due to any cause, whichever came first, assessed up to 1 year. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
40um Embozene TANDEM Microspheres
n=16 Participants
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Time To Tumor Progression
|
177.2 days
Standard Deviation 111.4
|
Adverse Events
40um Embozene TANDEM Microspheres
Serious adverse events
| Measure |
40um Embozene TANDEM Microspheres
n=18 participants at risk
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
Hepatobiliary disorders
Progression of Disease
|
55.6%
10/18 • Number of events 10 • Up to 24 months post procedure
|
Other adverse events
| Measure |
40um Embozene TANDEM Microspheres
n=18 participants at risk
40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)
40um Embozene TANDEM Microspheres: 40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
|
|---|---|
|
General disorders
Post Embolization Syndrome
|
77.8%
14/18 • Number of events 28 • Up to 24 months post procedure
|
|
Hepatobiliary disorders
Decreased Liver Function
|
33.3%
6/18 • Number of events 8 • Up to 24 months post procedure
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
2/18 • Number of events 2 • Up to 24 months post procedure
|
|
Immune system disorders
Allergic Reaction
|
11.1%
2/18 • Number of events 2 • Up to 24 months post procedure
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
|
General disorders
Anorexia
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
|
Injury, poisoning and procedural complications
Bone Fracture
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.6%
1/18 • Number of events 2 • Up to 24 months post procedure
|
|
General disorders
Edema
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
|
Surgical and medical procedures
Access Site Haemorrhage
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
|
General disorders
Hypochondrium Pain
|
5.6%
1/18 • Number of events 2 • Up to 24 months post procedure
|
|
Eye disorders
Visual Impairment
|
5.6%
1/18 • Number of events 1 • Up to 24 months post procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place