DRUG
CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Status
Active, not recruiting
Phase
Phase 3
Enrollment
332
Locations
86
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Octreotide LAR
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
DRUG
Lanreotide ATG
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
Timeline
From registration to results.
First posted
Sep 21, 2021
Study start
Oct 22, 2021
Primary completion
Nov 2026
Study completion
Nov 2028
Results posted
Not reported
Registry updated
Jul 28, 2026
Outcomes
What the study measures.
Primary outcomes
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
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
Overall survival
Time frame · Up to 2 years following the primary efficacy analysis
The time from the date of randomization to the date of death due to any cause
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
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)
Overall response rate
Time frame · From date of randomization until disease progression, assessed up to 48 months
The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1
Disease control rate
Time frame · From date of randomization until disease progression, assessed up to 48 months
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 to tumor response
Time frame · From date of randomization until disease progression, assessed up to 48 months
The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1
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
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
Incidence of treatment-emergent adverse events
Time frame · From screening to the safety follow-up, assessed up to 6 years
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
86 registered sites.
Australia · Belgium · Canada · France · Germany · Hungary · Israel · Italy · Netherlands · Romania · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic Cancer Center (MCCC) - Phoenix
Phoenix, Arizona, United States
UCLA Ahmanson Biological Imaging Center
Santa Monica, California, United States
Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, United States
Mayo Clinic Hospital - Florida
Jacksonville, Florida, United States
University of Kentucky (UK) - Markey Cancer Center
Lexington, Kentucky, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Texas Oncology - Austin
Austin, Texas, United States
Texas Oncology - Dallas
Dallas, Texas, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
GenesisCare - North Shore
Alexandria, Australia
Fiona Stanley Hospital
Murdoch, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hôpital Erasme
Brussels, Belgium
Antwerp University Hospital
Edegem, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
London Health Sciences Centre
London, Canada
Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital
Montreal, Canada
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