Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
This study will assess the pharmacokinetic profile and the safety/tolerability profile of
 single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with
 acromegaly and patients with carcinoid disease
Inclusion criteria for patients with acromegaly:

 -  Male or female patients between 18 and 80 years

 -  Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1
 concentrations

 Exclusion criteria for patients with acromegaly:

 -  Patients with compression of the optic chiasm causing any visual field defect

 -  Specific criteria apply for patients who have received certain types of therapies such
 as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study
 start

 -  Female patients who are pregnant or lactating

 Inclusion criteria for patients with carcinoid disease:

 -  Male or female patients aged ≥18 years

 -  Patients with histologically confirmed, metastatic carcinoid tumors of the digestive
 system

 -  Patients with elevation of chromogranin-A (CgA) and/or serotonin

 -  Patients who are not adequately controlled by somatostatin analogues

 Exclusion criteria for patients with carcinoid disease:

 -  Specific criteria apply for patients who have received certain types of therapies such
 as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study
 start

 -  Female patients who are pregnant or lactating

 Other protocol-defined in- and exclusion criteria may apply.