Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. 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.