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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2021-000849-40
Secondary ID [2] 0 0
HS-19-657
Universal Trial Number (UTN)
Trial acronym
SORENTO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-enteropancreatic Neuroendocrine Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Timepoint [1] 0 0
From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Up to 2 years following the primary efficacy analysis
Secondary outcome [2] 0 0
PFS as assessed by local Investigators
Timepoint [2] 0 0
From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
Secondary outcome [3] 0 0
Overall response rate
Timepoint [3] 0 0
From date of randomization until disease progression, assessed up to 48 months
Secondary outcome [4] 0 0
Disease control rate
Timepoint [4] 0 0
From date of randomization until disease progression, assessed up to 48 months
Secondary outcome [5] 0 0
Time to tumor response
Timepoint [5] 0 0
From date of randomization until disease progression, assessed up to 48 months
Secondary outcome [6] 0 0
Duration of response
Timepoint [6] 0 0
From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months
Secondary outcome [7] 0 0
Incidence of treatment-emergent adverse events
Timepoint [7] 0 0
From screening to the safety follow-up, assessed up to 6 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
Accrual to date
Final
332
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital (TQEH) - Adelaide
Recruitment hospital [2] 0 0
GenesisCare - North Shore - Alexandria
Recruitment hospital [3] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Alexandria
Recruitment postcode(s) [3] 0 0
- Blacktown
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Murdoch
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Kentucky
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Louisiana
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Massachusetts
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Minnesota
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New York
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Texas
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Utah
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Sint-Niklaas
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London
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Ulm
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Budapest
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Gyor
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Maastricht
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Rotterdam
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Suceava
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Spain
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A Coruña
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Barcelona
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Elche
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Girona
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Madrid
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Murcia
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Málaga
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Sabadell
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Spain
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Santander

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Camurus AB
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05050942
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Simron Singh, MD, MPH
Address 0 0
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05050942