Status:
TERMINATED
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Carcinoid Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- poorly differentiated or high grade neuroendocrine tumor
- significant cv, hepatic, renal or other disease
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00884715
Start Date
July 1 2009
End Date
December 1 2011
Last Update
September 20 2013
Active Locations (3)
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1
Iowa City, Iowa, United States, 52242
2
Boston, Massachusetts, United States, 02115
3
Burlington, Massachusetts, United States, 01805