Trial Outcomes & Findings for P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome (NCT NCT01886287)
NCT ID: NCT01886287
Last Updated: 2015-01-12
Results Overview
The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.
TERMINATED
PHASE2
2 participants
At 12 weeks
2015-01-12
Participant Flow
This study was open to accrual at Moffitt Cancer Center 12/10/2013 through 10/10/2014.
Participant milestones
| Measure |
Octreotide Long-acting Release (LAR)
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Octreotide Long-acting Release (LAR)
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm.
|
|---|---|
|
Overall Study
Radiographic disease progression
|
1
|
|
Overall Study
Clinical progression due to disease
|
1
|
Baseline Characteristics
P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Baseline characteristics by cohort
| Measure |
Octreotide Long-acting Release (LAR)
n=2 Participants
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Participants on study at 12 weeks
The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.
Outcome measures
| Measure |
Octreotide Long-acting Release (LAR)
n=1 Participants
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm.
|
|---|---|
|
Number of Participants With Improved Frequency of Diarrhea
|
1 participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Evaluable participants on study at 6 months
Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
Outcome data not reported
Adverse Events
Octreotide Long-acting Release (LAR)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Octreotide Long-acting Release (LAR)
n=2 participants at risk
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Octreotide LAR: Octreotide LAR as outlined in Treatment Arm.
|
|---|---|
|
General disorders
Edema limbs
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
General disorders
Edema trunk
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Bruising
|
50.0%
1/2 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • 3 months
|
Additional Information
Jonathan Strosberg, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place