Well differentiated, and low or intermediate grade (WHO classification G1-2) neuroendocrine tumor
Tumor size increase \< 10% in 6 months prior to screening on CT or MRI
Mean 24-hour urinary free cortisol level of at least 1.5 x the upper limit of the normal range, and a morning plasma ACTH level of \> 5 ng/L
You may not be if
Patients with highly malignant ACTH-secreting tumors, i.e. small-cell lung carcinomas, medullary thyroid carcinomas, and pheochromocytomas
Patients with poorly differentiated neuroendocrine tumors (WHO classification G3)
Patients with \>10% increase of tumor size in 6 months prior to screening by CT or MRI
Patients with Cushing's syndrome due to pituitary ACTH secretion
Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
Patients who have undergone major surgery within 1 month prior to screening
Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C \>8%
Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by
Congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry
QTcF \>450 msec at screening
* History of syncope or family history of idiopathic sudden death
* Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure
* Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, concomitant medication(s) known to increase the QT interval
Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST more than 2 x ULN, serum creatinine \>2.0 x ULN, serum bilirubin \>1.5 x ULN, serum albumin \< 0.67 x LLN at screening
Patients with any ongoing or planned anti-neoplastic therapy
Has been treated with radionuclide at any time prior to study entry
Is likely to require any additional concomitant treatment to pasireotide for the tumor
Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as
* 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
* Presence of active or suspected acute or chronic uncontrolled infection
* History of, or current alcohol misuse/abuse in the 12 month period prior to screening
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with pasireotide
Known hypersensitivity to somatostatin analogues
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
Patients with presence of Hepatitis B surface antigen (HbsAg)
Patients with presence of Hepatitis C antibody test (anti-HCV)
Clareo Health | SOM230 Ectopic ACTH-producing Tumors
