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Active, Not Recruiting

NCT Number: NCT05050942

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastro-enteropancreatic Neuroendocrine Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GenesisCare - North Shore, Alexandria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAM2029

Drug

CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection

Octreotide LAR

Drug

Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

Lanreotide ATG

Drug

Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

Primary outcomes

  1. Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)

    Time frame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months

    PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)

Secondary outcomes

  1. Overall survival

    Time frame: Up to 2 years following the primary efficacy analysis

    The time from the date of randomization to the date of death due to any cause

  2. PFS as assessed by local Investigators

    Time frame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months

    PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)

  3. Overall response rate

    Time frame: From date of randomization until disease progression, assessed up to 48 months

    The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1

  4. Disease control rate

    Time frame: From date of randomization until disease progression, assessed up to 48 months

    The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1

  5. Time to tumor response

    Time frame: From date of randomization until disease progression, assessed up to 48 months

    The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1

  6. Duration of response

    Time frame: From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months

    The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, as per BIRC according to RECIST 1.1

  7. Incidence of treatment-emergent adverse events

    Time frame: From screening to the safety follow-up, assessed up to 6 years

Sponsors and collaborators

Lead sponsor

Camurus AB

Industry

Registry information

Official study title

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

Acronym: SORENTO

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Sep 21, 2021
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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