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

HS-19-657

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.

2021-10-22

2024-12-01

2026-12-01

Active (not recruiting)

Early phase I

332

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 332, 'type': 'ACTUAL'}}

2024-01-26