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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446082

Enrollment

Registered

2007-03-12

Start date

2006-06-30

Completion date

2013-11-30

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly, Carcinoid Tumor

Keywords

Refractory/ resistant carcinoid disease, acromegaly, adults, pasireotide LAR, somatostatin analogue, SOM230, pharmacokinetics, Refractory or resistant carcinoid disease and acromegaly

Brief 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

Interventions

DRUGPasireotide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection	Baseline, D7, D35, D63	in patients with acromegaly and in patients with carcinoid disease

Secondary

Measure	Time frame	Description
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection	Baseline, D7, D35, D63	in patients with acromegaly and in patients with carcinoid disease.

Countries

Belgium, Canada, Germany, Netherlands, Norway, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026