Study on the Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients with Advanced GEP-NET
Sponsor: Camurus AB
ClinicalTrials ID:NCT05050942
This clinical trial is evaluating a new treatment, CAM2029, compared to existing treatments for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET). Patients whose disease worsens during the study may receive an intensified treatment with CAM2029.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to compare how well a new treatment, CAM2029, works and how safe it is compared to current treatments, octreotide LAR or lanreotide ATG, in patients with advanced GEP-NET. If a patient's condition worsens during the study, they may have the option to receive a more intensive treatment with CAM2029 in a follow-up part of the study.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced, well-differentiated neuroendocrine tumors (NET) of the gastroenteropancreatic (GEP) system or presumed GEP origin.
- Have at least one measurable tumor that shows up on specific scans and tests.
- Be in relatively good health, with an ECOG performance status score between 0 and 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have evidence of disease progression while on treatment for advanced or metastatic disease.
- Have known cancer spread to the brain or central nervous system.
- Have been on long-acting somatostatin analogs (SSAs) for more than 6 months before joining the study.
- Have carcinoid symptoms that do not respond to standard doses of octreotide LAR or lanreotide ATG, or to daily doses of octreotide IR.
- Have had more than one cycle of certain targeted therapies, chemotherapy, or interferon for GEP-NET.
- Have had specific treatments like trans-arterial chemoembolization or embolization within 12 months before joining the study.
- Have received radioligand therapy (PRRT) at any time.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Cancer Center (MCCC) - Phoenix | 85054 | Phoenix | Arizona |
| UCLA Ahmanson Biological Imaging Center | 90404 | Santa Monica | California |
| Rocky Mountain Cancer Centers - Denver - Midtown | 80218 | Denver | Colorado |
| Mayo Clinic Hospital - Florida | 32224 | Jacksonville | Florida |
| Anderson Family Cancer Institute | 33469 | Jupiter | Florida |
| University of Kentucky (UK) - Markey Cancer Center | 40536 | Lexington | Kentucky |
| East Jefferson General Hospital | 70065 | Metairie | Louisiana |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Mayo Clinic Rochester | 55905 | Rochester | Minnesota |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
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