Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Phase 1/Phase 2
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Carcinoid Syndrome
Both
Carcinoid Syndrome
Trial Information
Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at
2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9
months.
Inclusion Criteria:
- histologically confirmed tumor
- documented evidence of carcinoid syndrome
- life expectancy of at least 6 months
- previous positive octreotide scan
- received stable doses of octreotide injections
- performance status of 0-2 on the ECOG performance scale
Exclusion Criteria:
- poorly differentiated or high grade neuroendocrine tumor
- significant cv, hepatic, renal or other disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea
Outcome Time Frame:
9 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
IP107-002
NCT ID:
NCT00884715
Start Date:
July 2009
Completion Date:
December 2011
Related Keywords:
- Carcinoid Syndrome
- Carcinoid Tumor
- Malignant Carcinoid Syndrome
- Serotonin Syndrome
Name | Location |
|---|---|
| Bettendorf, Iowa 52722 | |
| Boston, Massachusetts |
