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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

Short name SORENTO

NCTNCT05050942 (opens ClinicalTrials.gov in a new tab)Other idHS-19-657Other id2023-508723-12-00Other id2021-000849-40Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
332 participants (actual)
Sponsor
Camurus AB · Industry
Design
Randomized · Open label (no masking)
Countries
12 countries

United States, Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Romania, Spain

Start
22 Oct 2021
Primary completion
Nov 2026 (estimated)
Completion
Nov 2028 (estimated)
First posted
21 Sept 2021
Last update posted
28 Jul 2026
Conditions
Gastro-enteropancreatic Neuroendocrine Tumor

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202420262028
  1. Ph 3

    SORENTO

    NCT05050942

    22 Oct 2021 to est. Nov 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CAM2029Drug
  • Octreotide LARDrug
  • Lanreotide ATGDrug

Arms2

  • Experimental

    CAM2029

  • Active comparator

    Octreotide LAR or lanreotide ATG

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(7)

  1. Overall survival

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2024

Corrected

Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET.

Singh et al. 2024Trialscited by 5

PMID 38229199PMC10790497DOI 10.1186/s13063-023-07834-8PUB-38229199

CC BY
Download PDFRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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