Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
NCT ID: NCT00446082
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2006-06-30
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SOM230 LAR
Pasireotide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pasireotide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis
Role: STUDY_CHAIR
Novartis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Resendiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. J Clin Pharmacol. 2014 Nov;54(11):1308-17. doi: 10.1002/jcph.326. Epub 2014 May 24.
Related Links
Access external resources that provide additional context or updates about the study.
Novartis Clinical Trial Results for CSOM230C2110
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005-003348-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSOM230C2110
Identifier Type: -
Identifier Source: org_study_id