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Completed

NCT Number: NCT00446082

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pasireotide

Drug

Primary outcomes

  1. Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection

    Time frame: Baseline, D7, D35, D63

    in patients with acromegaly and in patients with carcinoid disease

Secondary outcomes

  1. To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection

    Time frame: Baseline, D7, D35, D63

    in patients with acromegaly and in patients with carcinoid disease.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2007
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.