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A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

NCT05050942

Active Not RecruitingPhase 3

Sponsor: Camurus AB

Conditions: Gastro-enteropancreatic Neuroendocrine Tumor

Interventions: CAM2029, Octreotide LAR, Lanreotide ATG

Countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Israel

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female patient ≥18 years old
* Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
* At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
* ECOG performance status of 0 to 2

Exclusion Criteria:

* Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
* Known central nervous system metastases
* Consecutive treatment with long-acting SSAs for more than 6 months before randomization
* Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
* Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
* Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
* Previously received radioligand therapy (PRRT) at any time
Locations (86)
  • Phoenix, Arizona, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Jacksonville, Florida, United States
  • Lexington, Kentucky, United States
  • Metairie, Louisiana, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • McAllen, Texas, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Alexandria, Australia
  • Murdoch, Australia
  • Brussels, Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Ghent, Belgium
  • Sint-Niklaas, Belgium
  • London, Canada
  • Montreal, Canada
  • Montreal, Canada
  • Ottawa, Canada
  • St. Catharines, Canada
  • Toronto, Canada
  • Toronto, Canada
  • Vancouver, Canada
  • + 56 more on CT.gov