Trial Outcomes & Findings for A Pilot Study of Pre- and Post-operative Use of Somatuline Depot. (NCT NCT01861717)
NCT ID: NCT01861717
Last Updated: 2021-09-30
Results Overview
Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.
TERMINATED
PHASE4
4 participants
3 months post-op
2021-09-30
Participant Flow
recruited between May 2013 and January 2016, in outpatient cancer center clinic
Participant milestones
| Measure |
Somatuline Depot Subcutaneous (SC)
Somatuline Depot Subcutaneous (SC) 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.
lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Somatuline Depot Subcutaneous (SC)
Somatuline Depot Subcutaneous (SC) 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.
lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Baseline characteristics by cohort
| Measure |
Somatuline Depot SC
n=4 Participants
Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.
lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
|
|---|---|
|
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
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 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
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post-opPopulation: 2 patients treated; data not analyzed because study terminated prematurely.
Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 month post-opPopulation: 2 patients treated; data not analyzed because study terminated prematurely.
Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2 patients treated; data not analyzed because study terminated prematurely.
Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks and 3 monthsPopulation: 2 patients treated; data not analyzed because study terminated prematurely.
Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2 patients treated; data not analyzed because study terminated prematurely.
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-opPopulation: 2 patients treated; data not analyzed because study terminated prematurely.
Remission status one year after surgery and time to achieve remission in patients who did not achieve remission after endonasal endoscopic surgery and who had resumption of Somatuline Depot therapy 3 months after surgery.
Outcome measures
Outcome data not reported
Adverse Events
Somatuline Depot SC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Somatuline Depot SC
n=2 participants at risk
Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction.
lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
|
|---|---|
|
Nervous system disorders
Headache
|
100.0%
2/2 • Number of events 2 • 15 months
|
|
Investigations
weight loss
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
urinary frequency
|
100.0%
2/2 • Number of events 2 • 15 months
|
|
Gastrointestinal disorders
abdominal pain
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Eye disorders
blurred vision
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
General disorders
pain
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
anemia
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
anorexia
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
General disorders
fatigue
|
50.0%
1/2 • Number of events 1 • 15 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
50.0%
1/2 • Number of events 1 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place