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

Novartis

Status and phase

Completed

Phase 1

Conditions

Carcinoid Tumor

Acromegaly

Treatments

Drug: Pasireotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00446082

CSOM230C2110

2005-003348-75 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.