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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT00446082 (opens ClinicalTrials.gov in a new tab)Other idCSOM230C2110Other id2005-003348-75Other id2005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
85 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
6 countries

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

Start
Jun 2006
Primary completion
Nov 2013
Completion
Nov 2013
First posted
12 Mar 2007 (estimated)
Last update posted
21 Dec 2020
Conditions
Carcinoid Tumor · Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062008201020122014
  1. Ph 1

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

    NCT00446082

    Jun 2006 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PasireotideDrug

Arms1

  • Experimental

    SOM230 LAR

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, D7, D35, D63

    Registry description

    in patients with acromegaly and in patients with carcinoid disease

Secondary outcomes(1)

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

    Time frame · Baseline, D7, D35, D63

    Registry description

    in patients with acromegaly and in patients with carcinoid disease.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

11 results

Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study.

Petersenn et al. 2014Journal of clinical pharmacologycited by 23

PMID 24800725DOI 10.1002/jcph.326PUB-24800725

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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