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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

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
2023-508723-12-00
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
1/12/2027
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
Country [1] 0 0
United States of America
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Arizona
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California
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Colorado
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Florida
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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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London
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Ulm
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Gyor
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Rotterdam
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Romania
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Bucharest
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Cluj-Napoca
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Suceava
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Girona
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Sabadell
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05050942