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

  • End date
    Dec 27, 2026
  • participants needed
  • sponsor
    Camurus AB
Updated on 27 August 2023


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.

Condition Gastro-enteropancreatic Neuroendocrine Tumor
Treatment Octreotide LAR, CAM2029, Lanreotide ATG
Clinical Study IdentifierNCT05050942
SponsorCamurus AB
Last Modified on27 August 2023


Yes No Not Sure

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
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