ClinicalTrials.gg
Active, not recruitingNCT05050942SORENTOUpdated Jul 28, 2026

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

A Phase 3 interventional study of CAM2029 and Octreotide LAR in Gastro-enteropancreatic Neuroendocrine Tumor, sponsored by Camurus AB. Active, not recruiting at 86 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Camurus AB · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gastro-enteropancreatic Neuroendocrine Tumor

Keywords

  • CAM2029
  • GEP-NET
  • Octreotide
  • SORENTO
03

In context

Gastro-enteropancreatic neuroendocrine tumor

72 studies on the registry are indexed under Gastro-enteropancreatic neuroendocrine tumor; 24 are open to participants now.

This study's enrollment of 332 is above the median of 53 across 48 interventional studies indexed under Gastro-enteropancreatic neuroendocrine tumor.

Browse Gastro-enteropancreatic neuroendocrine tumor studies →

Lead sponsor

Camurus AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female patient ≥18 years old
  • confirmed, advanced (unresectable and/or ), and well-differentiated NET of GEP or presumed GEP origin
  • At least 1 measurable, somatostatin receptor-positive lesion according to 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
  • performance status of 0 to 2

Exclusion criteria

Exclusion Criteria:

  • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or disease
  • Known central nervous system metastases
  • Consecutive treatment with long-acting SSAs for more than 6 months before randomization
  • Carcinoid symptoms that are 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
332 participants (actual)

Study arms

  • Experimental
    CAM2029

    Drug: CAM2029

  • Active comparator
    Octreotide LAR or lanreotide ATG

    Drug: Octreotide LAR · Drug: Lanreotide ATG

Interventions

  • DrugCAM2029

    Drug pages: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029

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

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

  • DrugLanreotide ATG

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

06

What researchers measure

Primary outcomes

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

    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)

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

Secondary outcomes

  1. Overall survival

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

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

  2. PFS as assessed by local Investigators

    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)

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

  3. Overall response rate

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

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

  4. Disease control rate

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

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

  5. Time to tumor response

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

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

  6. Duration of response

    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

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

  7. Incidence of treatment-emergent adverse events

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

07

Study locations

86 sites
08

References and documents

Publications

  • Singh S, Ferone D, Capdevila J, Chan JA, de Herder WW, Halperin D, Mailman J, Hellstrom L, Liedman H, Svedberg A, Tiberg F. 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. Trials. 2024 Jan 16;25(1):58. doi: 10.1186/s13063-023-07834-8. PubMed 38229199 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05050942
Lead sponsor
Camurus AB
Responsible party
Sponsor
First posted
Sep 21, 2021
Start date
Oct 22, 2021
Primary completion
Nov 2026 (estimated)
Completion
Nov 2028 (estimated)
Last update
Jul 28, 2026

Study contacts

Simron Singh, MD, MPH
principal investigator · Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029

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