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

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Camurus AB
• Treatments: Angiopeptin; Lanreotide; Octreotide

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