Number of Participants With Improved Frequency of Diarrhea
| Group | Value (participants) |
|---|---|
| Octreotide Long-acting Release (LAR) | 1 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Slow accrual
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
NCT01886287Dec 2013 to Oct 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing, diarrhea, and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR.
Experimental
Octreotide Long-acting Release (LAR)
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Outcomes the sponsor listed as primary.
Number of Participants With Improved Frequency of Diarrhea
Time frame · 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.
Rate of Progression Free Survival (PFS) at 6 Months
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Octreotide Long-acting Release (LAR) | 1 |
| Group | Value |
|---|---|
| Octreotide Long-acting Release (LAR) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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. | – | 0 / 2 | 2 / 2 |
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