Study on the Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients with Advanced GEP-NET

Sponsor: Camurus AB

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Mayo Clinic Cancer Center (MCCC) - Phoenix85054PhoenixArizona
UCLA Ahmanson Biological Imaging Center90404Santa MonicaCalifornia
Rocky Mountain Cancer Centers - Denver - Midtown80218DenverColorado
Mayo Clinic Hospital - Florida32224JacksonvilleFlorida
Anderson Family Cancer Institute33469JupiterFlorida
University of Kentucky (UK) - Markey Cancer Center40536LexingtonKentucky
East Jefferson General Hospital70065MetairieLouisiana
Dana-Farber Cancer Institute02215BostonMassachusetts
Mayo Clinic Rochester55905RochesterMinnesota
Memorial Sloan-Kettering Cancer Center10065New YorkNew York

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