An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors

Study start date: January 1, 2004

Inclusion Criteria: * Patients with biopsy-proven metastatic carcinoid tumors * Patients with at least one measurable lesion (excluding bone) * Patients must be considered inadequately controlled while on Sandostatin LAR therapy based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as experiencing a minimum average of at least four bowel movements per day or a minimum average of at least two episodes of flushing per day Exclusion Criteria: * Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study * Patients who have undergone major recent surgery / surgical therapy for any cause within 1 month * Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months * Patients with uncontrolled diabetes mellitus * Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy * Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a history of acute myocardial infarction within the three months preceding enrollment * Patients with chronic liver disease * Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. * History of immunocompromise, including a positive HIV test result * Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230 * Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230 * Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing * Patients with additional active malignant disease within the last five years