Trial Outcomes & Findings for Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC) (NCT NCT01464593)
NCT ID: NCT01464593
Last Updated: 2022-10-13
Results Overview
Subject's treated with thermal ablation in conjunction with Thermodox to evaluate local tumor control defined as complete ablation and does not experience recurrence within 1 cm of the ablation site.
TERMINATED
PHASE2
2 participants
1 year
2022-10-13
Participant Flow
Participant milestones
| Measure |
Thermodox
Thermodox 50 mg/m2 intravenous infusion over 30 minutes starting 15 minutes before thermal ablation.
Lyso-Thermosensitive Liposomal Doxorubicin: Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.
5% Dextrose Solution: Single 30 minute intravenous infusion
ThermoDox: ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Thermodox
Thermodox 50 mg/m2 intravenous infusion over 30 minutes starting 15 minutes before thermal ablation.
Lyso-Thermosensitive Liposomal Doxorubicin: Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.
5% Dextrose Solution: Single 30 minute intravenous infusion
ThermoDox: ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.
|
|---|---|
|
Overall Study
Study terminated early due to lack of enrollment
|
1
|
Baseline Characteristics
Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC)
Baseline characteristics by cohort
| Measure |
Thermodox
n=1 Participants
Thermodox 50 mg/m2 intravenous infusion over 30 minutes starting 15 minutes before thermal ablation.
Lyso-Thermosensitive Liposomal Doxorubicin: Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.
5% Dextrose Solution: Single 30 minute intravenous infusion
ThermoDox: ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.
|
|---|---|
|
Age, Continuous
|
41 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Study terminated early due to lack of enrollment and data were not collected
Subject's treated with thermal ablation in conjunction with Thermodox to evaluate local tumor control defined as complete ablation and does not experience recurrence within 1 cm of the ablation site.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Study terminated early due to lack of enrollment and data were not collected
Adverse events will be assessed through 1 month following study treatment(s). AE's after 1 month through the Month 25 assessment are reported if possibly, probably, or definitely related to study drug. Safety data will include physical exams, vital signs, ECGs, Echocardiograms/MUGA Scans, hematology, clinical chemistry and urinalysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study terminated early due to lack of enrollment and data were not collected
Measured as the time to local recurrence after ablation as measured from the date of randomization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Study terminated early due to lack of enrollment and data were not collected
Measured as time from randomization to death or the end of the study at month 37.
Outcome measures
Outcome data not reported
Adverse Events
Thermodox
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place