CLINICAL TRIAL: SOM230 IM LAR INJECTION IN PATIENTS WITH ACROMEGALY AND CARCIN

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. GH-secreting pituitary adenomas (causing the syndrome of Acromegaly) and Neuroendocrine tumors(causing carcinoid disease), express somatostatin receptors. Currently available somatostatin analogs bind to only some of these receptors, and are therefore effective at controlling these diseases a fraction of the time. SOM230 is a novel somatostatin analogue that binds with higher affinity to four of the five known human somatostatin receptors, and therefore may be more effective. Critical to the SOM230 program is a viable monthly long-acting release (LAR) formulation which provides sufficient pharmacological activity with minimal safety/tolerability concerns in both patients with acromegaly and patients with carcinoid disease. The ideal SOM230 LAR formulation should provide sustained drug levels for approximately 28 days and exhibit acceptable safety and tolerability. The primary purpose of this study is to show sustained drug levels, safety, and tolerability of SOM230 LAR in patients with Acromegaly and Carcinoid disease. A secondary purpose of this study is to assess the pharmacodynamics of SOM 230 LAR for Acromegaly/Carcinoid (i.e. to obtain proof of concept evidence for its efficacy).