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.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00446082

First received: March 9, 2007

Last updated: September 28, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2007

Last Updated Date

September 28, 2012

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00446082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Carcinoid Tumor
Acromegaly

Intervention ^ICMJE

Drug: Pasireotide

Study Arm (s)

Experimental: SOM230 LAR

Intervention: Drug: Pasireotide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00446082

Other Study ID Numbers ^ICMJE

CSOM230C2110, 2005-003348-75

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Novartis

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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