Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome

Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of 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