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

This study is ongoing, but not recruiting participants.

First Received on March 9, 2007. Last Updated on March 14, 2012 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
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 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Carcinoid Tumors

U.S. FDA Resources

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 [ Time Frame: Baseline, D7, D35, D63 ] [ Designated as safety issue: No ]
in patients with acromegaly and in patients with carcinoid disease

Secondary Outcome Measures:

To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection [ Time Frame: Baseline, D7, D35, D63 ] [ Designated as safety issue: No ]
in patients with acromegaly and in patients with carcinoid disease.

Estimated Enrollment:	77
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SOM230 LAR	Drug: Pasireotide

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
Novartis Investigative Site
Los Angeles, California, United States, 90048
Novartis Investigative Site
Stanford, California, United States, 94304
United States, Florida
Novartis Investigative Site
Tampa, Florida, United States, 33612
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030-4009
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1200
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Liege, Belgium, 4000
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada, N6A 4L6
Novartis Investigative Site
Toronto, Ontario, Canada, M5G1X5
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4M1
Germany
Novartis Investigative Site
Berlin, Germany, 12200
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Leipzig, Germany, 04317
Novartis Investigative Site
Muenchen, Germany, 80336
Netherlands
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Norway
Novartis Investigative Site
Oslo, Norway, NO-0424

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals
Study Chair:	Novartis	Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00446082 History of Changes
Other Study ID Numbers:	CSOM230C2110, 2005-003348-75
Study First Received:	March 9, 2007
Last Updated:	March 14, 2012
Health Authority:	United States: Food and Drug Administration 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

Keywords provided by Novartis:

Refractory/ resistant carcinoid disease
acromegaly
adults
pasireotide LAR

somatostatin analogue
SOM230
pharmacokinetics
Refractory or resistant carcinoid disease and acromegaly

Additional relevant MeSH terms:

Acromegaly
Carcinoid Tumor
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Endocrine System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 22, 2012