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: October 18, 2013
Last verified: October 2013

March 9, 2007
October 18, 2013
June 2006
November 2013   (final data collection date for primary outcome measure)
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
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
Complete list of historical versions of study NCT00446082 on ClinicalTrials.gov Archive Site
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.
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
Not Provided
Not Provided
 
Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoid Tumor
  • Acromegaly
Drug: Pasireotide
Experimental: SOM230 LAR
Intervention: Drug: Pasireotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
November 2013
November 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Netherlands,   Norway
 
NCT00446082
CSOM230C2110, 2005-003348-75
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
Novartis
October 2013

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