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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pasireotide

Criteria

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.