| Exclusion Criteria: | 1) Patients who cannot tolerate the SOM230 s.c. test injection
2) Patients who have received radiolabeled somatostatin analogue therapy within the last 6 months prior to receiving SOM230
3) Patients who have undergone major surgery / surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months
4) Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months
5) Patients who had received radiotherapy for any reason within the last 4 weeks must have recovered from any side effects of radiotherapy
6) Patients with hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or patients who have undergone cryoablation of hepatic metastasis within the last 2 months
7) Patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
8) Patients with symptomatic cholelithiasis
9) Patients with uncontrolled diabetes mellitus as indicated by the presence of ketoacidosis or HbA1C > 10%
10) Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)
11) Patients receiving anticoagulants that affect PT (prothrombin time) or PTT (activated partial thromboplastin time)
12) Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, bradycardia, advanced heart block or a history of acute myocardial infarction within the three months preceding enrollment: • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval ' 450 ms); • A history of additional risk factors for Torsade de Pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome); • The use of concomitant medications that prolong the QT/ QTc interval
13) Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or patients with ALT/AST more than 2 X ULN, serum creatinine >2.0 X ULN, serum bilirubin >2.0 X ULN, serum albumin < 0.67 X LLN, and/ or ALT/AST more than 2 X ULN for patients without liver metastases or ALT/AST more than 5X ULN for patients with documented liver metastases.
14) Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor's Medical Monitor
15) Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use barrier contraception with condoms. If oral contraception is used, the patient must have been practicing this method for at least two months prior to the enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for 3 months afterwards.
16) History of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
17) Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving SOM230
18) Patients who have given a blood donation (of 400 mL or more) within 2 months before receiving SOM230
19) Patients who have participated in any clinical investigation with an investigational drug (other then SOM230) within 1 month prior to dosing
20) Known hypersensitivity to somatostatin analogues
21) Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
22) Patients with the presence of active or suspected acute or chronic uncontrolled infection
23) Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study |