Trial Outcomes & Findings for Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis (NCT NCT02443103)
NCT ID: NCT02443103
Last Updated: 2018-02-13
Results Overview
Number of patients who had blood specimens taken to collect and evaluate markers of bone formation and bone resorption. Note - due to poor accrual and early closure, bone marker data was not collected.
TERMINATED
NA
4 participants
Day 0, Week 8, Week 12
2018-02-13
Participant Flow
This protocol was based on enrolling 15 patients. Due to poor accrual and the decision that the approach with this agent is not feasible, the study was closed with 4 patients enrolled.
Participant milestones
| Measure |
Guanabenz
Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Guanabenz
Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Noncompliance
|
1
|
Baseline Characteristics
Study Evaluating the Biologic Activity of Guanabenz in Bone Metastasis
Baseline characteristics by cohort
| Measure |
Guanabenz
n=4 Participants
Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 2.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, Week 8, Week 12Population: All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit with bone marker information available.
Number of patients who had blood specimens taken to collect and evaluate markers of bone formation and bone resorption. Note - due to poor accrual and early closure, bone marker data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: All patients enrolled and received treatment.
Number of unique patients who had a treatment related (possible, probable or definite) adverse events.
Outcome measures
| Measure |
Guanabenz
n=4 Participants
Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
|
|---|---|
|
Treatment Related Adverse Events
|
2 Participants
|
Adverse Events
Guanabenz
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Guanabenz
n=4 participants at risk
Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
2/4 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Up to 1 year
|
|
General disorders
Fatigue
|
25.0%
1/4 • Up to 1 year
|
|
General disorders
Pain
|
25.0%
1/4 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Up to 1 year
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Up to 1 year
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place