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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00446082

Purpose

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

Condition	Intervention	Phase
Carcinoid Tumor Acromegaly	Drug: Pasireotide	Phase I

MedlinePlus related topics: Cancer Carcinoid Tumors

Drug Information available for: Somatostatin Pasireotide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official 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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446082

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Standford, California, United States
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
United States, Ohio
OSU Medical Center/James Cancer Hospital
Columbus, Ohio, United States
United States, Texas
University of Texas/MD Anderson Cancer Center
Houston, Texas, United States
Belgium

Leuven, Belgium
Canada

London, Ontario, Canada

Montreal, Quebec, Canada

Toronto, Ontario, Canada
Germany

Essen, Germany

Berlin, Germany

Munchen, Germany

Leipzig, Germany
Netherlands

Rotterdam, Netherlands

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSOM230C2110
Study First Received:	March 9, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00446082
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; United States: Food and Drug Administration

Keywords provided by Novartis:

Refractory/ resistant carcinoid disease
acromegaly
adults
pasireotide LAR

somatostatin analogue
SOM230
pharmacokinetics
Refractory or resistant carcinoid disease and acromegaly

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Brain Diseases
Bone Diseases
Somatostatin
Carcinoma
Neuroendocrine Tumors

Carcinoid tumor
Neuroectodermal Tumors
Musculoskeletal Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carcinoid Tumor
Endocrinopathy
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Acromegaly

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Hyperpituitarism
Neoplasms, Nerve Tissue
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009