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

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Brief Title

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

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

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
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Carcinoid Tumor

Intervention

Pasireotide

Study Arms / Comparison Groups

 SOM230 LAR
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

85

Start Date

June 2006

Completion Date

November 2013

Primary Completion Date

November 2013

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT00446082

Organization ID

CSOM230C2110

Secondary IDs

2005-003348-75

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals


Verification Date

November 2016