DRUG
Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
Status
Completed
Phase
Phase 1
Enrollment
85
Locations
17
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 12, 2007
Study start
Jun 2006
Primary completion
Nov 2013
Study completion
Nov 2013
Results posted
Not reported
Registry updated
Dec 21, 2020
Outcomes
What the study measures.
Primary outcomes
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
Time frame · Baseline, D7, D35, D63
in patients with acromegaly and in patients with carcinoid disease
Secondary outcomes
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
Time frame · Baseline, D7, D35, D63
in patients with acromegaly and in patients with carcinoid disease.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
17 registered sites.
Belgium · Canada · Germany · Netherlands · Norway · United States. Showing up to 24 locations stored in the fast local snapshot.
Cedars Sinai Medical Center SC - 4
Los Angeles, California, United States
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States
H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
Tampa, Florida, United States
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Rotterdam, Netherlands
Novartis Investigative Site
Oslo, Norway
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