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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Novartis Investigative Site, Brussels, Belgium
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
Primary outcomes
-
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
-
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.
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