Trial Outcomes & Findings for Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor (NCT NCT01372618)
NCT ID: NCT01372618
Last Updated: 2017-12-27
Results Overview
Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).
TERMINATED
PHASE1/PHASE2
9 participants
Before and after 20 days of treatment
2017-12-27
Participant Flow
Participant milestones
| Measure |
SOM 230/Pasireotide
Treatment with SOM230 600mcg twice daily for 20 days.
SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
SOM 230/Pasireotide
Treatment with SOM230 600mcg twice daily for 20 days.
SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously.
|
|---|---|
|
Overall Study
PI Died. Study Terminated
|
9
|
Baseline Characteristics
Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor
Baseline characteristics by cohort
| Measure |
SOM 230/Pasireotide
n=9 Participants
Treatment with SOM230 600mcg twice daily for 20 days.
SOM 230 / Pasireotide: SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after 20 days of treatmentPopulation: PI death. Study terminated
Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before and after 20 days of treatmentPopulation: PI death. Study terminated
To determine whether pasireotide prevents angiogenesis in DCIS as it does in the rat mammary gland, we will immunostain tissue samples for Factor VIII to identify vessels in DCIS before and after treatment. Further, using dynamic contrast enhanced MRI (DCE-MRI) we plan to detect changes in angiogenesis in vivo, non-invasively, and also detect effects of pasireotide which theoretically should inhibit vascularity. We propose to evaluate changes in the size of the lesion, changes in the morphologic appearance and kinetic features of the lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before and after 20 days of treatment with 3 month post-treatment follow-upPopulation: PI death. Study terminated
In our previous study, we found that women had moderately increased blood sugar early after starting SOM230. In other studies in normal individuals this effect disappeared by a week or two. We found some evidence of improvement during administration. However, extending the treatment period from 9.5 to 19.5 days will enable us to make certain that the early elevated sugar associated with SOM230 is only temporary.
Outcome measures
Outcome data not reported
Adverse Events
SOM 230/Pasireotide
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