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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
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
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
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
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
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
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
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
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
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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
Anderson Family Cancer Institute
Jupiter, 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
...and 88 more locations
Time frame: From date of randomization until disease progression, assessed up to 48 months
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
Incidence of treatment-emergent adverse events
Time frame: From screening to the safety follow-up, assessed up to 6 years