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

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