| Exclusion Criteria: | 1) Patients who have received pituitary irradiation within the last ten years prior to visit 1, as the onset time of the radiation effects cannot be determined
2) Patients who have been treated with mitotane during the last 6 months.
3) Patients with compression of the optic chiasm causing any visual field defect, in order to exclude patients with a tumor causing chiasma compression requiring surgery
4) Patients with Cushing's syndrome due to ectopic ACTH secretion
5) Patients with hypercortisolism secondary to adrenal tumors or Nodular (primary) bilateral adrenal hyperplasia
6) Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
7) Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
8) Patients who are hypothyroid and not on adequate replacement therapy
9) Patients who have undergone major surgery within 1 month prior to starting the study
10) Patients with symptomatic cholelithiasis
11) Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as evidenced by HbA1C >8%
12) Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
13) Patients receiving anticoagulants that affect PT or PTT
14) Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically symptomatic bradycardia, advanced heart block, history of acute myocardial infarction less than one year prior to study entry or clinically significant impairment in cardiovascular function
15) Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTc >480 ms, hypokalemia, family history of long QT syndrome, and concomitant medications known to prolong QT interval
16) 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
17) Patients with WBC <3 X 10^9/L; Hgb < LLN: PLT<100x10*9/L
18) Patients who have any current or prior medical condition that can 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
19) Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for 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 enrollment and must agree to continue the oral contraceptive throughout the course of the study and for one month after the last dose of study drug. Male patients who are sexually active are required to use condoms during the study and for 1 month afterwards
20) History of immunocompromise, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
21) Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide
22) Patients who have given a blood donation (of 400 ml or more) within 2 months before receiving pasireotide
23) Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing and patients who have been treated with pasireotide.
24) Known hypersensitivity to somatostatin analogues
25) Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
26) Patients with the presence of active or suspected acute or chronic uncontrolled infection
27) 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 |