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

Camarus

Status and phase: Active, not recruiting; Phase 3

Conditions: Gastro-enteropancreatic Neuroendocrine Tumor

Treatments: Drug: CAM2029; Drug: Lanreotide ATG; Drug: Octreotide LAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05050942

2021-000849-40 (EudraCT Number)

2023-508723-12-00 (EU Trial (CTIS) Number)

HS-19-657

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

CAM2029

Experimental group

Treatment:

Drug: CAM2029

Octreotide LAR or lanreotide ATG

Active Comparator group

Treatment:

Drug: Octreotide LAR

Drug: Lanreotide ATG