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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05050942
Registration number
NCT05050942
Ethics application status
Date submitted
9/09/2021
Date registered
21/09/2021
Date last updated
26/01/2024
Titles & IDs
Public title
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
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Scientific 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
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Secondary ID [1]
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2021-000849-40
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Secondary ID [2]
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HS-19-657
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Universal Trial Number (UTN)
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Trial acronym
SORENTO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastro-enteropancreatic Neuroendocrine Tumor
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CAM2029
Treatment: Drugs - Octreotide LAR
Treatment: Drugs - Lanreotide ATG
Experimental: CAM2029 -
Active Comparator: Octreotide LAR or lanreotide ATG -
Treatment: Drugs: CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
Treatment: Drugs: Octreotide LAR
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
Treatment: Drugs: Lanreotide ATG
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
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Assessment method [1]
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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)
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Timepoint [1]
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From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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The time from the date of randomization to the date of death due to any cause
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Timepoint [1]
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Up to 2 years following the primary efficacy analysis
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Secondary outcome [2]
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PFS as assessed by local Investigators
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Assessment method [2]
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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)
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Timepoint [2]
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From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
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Secondary outcome [3]
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Overall response rate
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Assessment method [3]
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The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1
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Timepoint [3]
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From date of randomization until disease progression, assessed up to 48 months
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Secondary outcome [4]
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Disease control rate
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Assessment method [4]
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The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1
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Timepoint [4]
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From date of randomization until disease progression, assessed up to 48 months
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Secondary outcome [5]
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Time to tumor response
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Assessment method [5]
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The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1
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Timepoint [5]
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From date of randomization until disease progression, assessed up to 48 months
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Secondary outcome [6]
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Duration of response
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Assessment method [6]
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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
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Timepoint [6]
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From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months
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Secondary outcome [7]
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Incidence of treatment-emergent adverse events
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Assessment method [7]
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Timepoint [7]
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From screening to the safety follow-up, assessed up to 6 years
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
332
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Queen Elizabeth Hospital (TQEH) - Adelaide
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Recruitment hospital [2]
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GenesisCare - North Shore - Alexandria
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Blacktown Hospital - Blacktown
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Peter MacCallum Cancer Centre - Melbourne
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Fiona Stanley Hospital - Murdoch
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- Adelaide
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- Alexandria
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- Blacktown
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- Melbourne
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Recruitment postcode(s) [5]
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- Murdoch
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Recruitment outside Australia
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Santander
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Camurus AB
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05050942
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Simron Singh, MD, MPH
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Address
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Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05050942
Download to PDF