NCT05050942

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

A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Camurus AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastro-enteropancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	CAM2029	CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
DRUG	Octreotide LAR	Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
DRUG	Lanreotide ATG	Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

Timeline

• Start date: 2021-10-22
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2021-09-21
• Last updated: 2025-11-06

Locations

98 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Romania, Spain

Regulatory

• FDA-regulated drug study