Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
NCT ID: NCT01364415
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
29 participants
INTERVENTIONAL
2011-08-31
2016-04-30
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.
Pasireotide LAR
Pasireotide LAR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pasireotide LAR
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* unresectable metastatic NET tumor with measurable disease
* life expectancy ≥ 12 weeks
Exclusion Criteria
* patients with known hypersensitivity to somatostatin analogs
* patients with symptomatic cholelithiasis in the past 2 months
* patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
* patients with known history of hepatitis C or chronic active hepatitis B
* patients with diagnosis of HIV.
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
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Institute SC-1
Tampa, Florida, United States
Dana Farber Cancer Institute SC-6
Boston, Massachusetts, United States
University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr
Houston, Texas, United States
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.
Yao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Resendiz K, Hu K, Ravichandran S, Strosberg JR, Wolin EM. Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors. Onco Targets Ther. 2017 Jun 27;10:3177-3186. doi: 10.2147/OTT.S128547. eCollection 2017.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CSOM230D2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CSOM230D2101
Identifier Type: -
Identifier Source: org_study_id