Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

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 evaluating 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