A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET
- Conditions
- Gastro-enteropancreatic Neuroendocrine Tumor
- Interventions
- Registration Number
- NCT05050942
- Lead Sponsor
- Camurus AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 332
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Octreotide LAR or lanreotide ATG Octreotide LAR - Octreotide LAR or lanreotide ATG Lanreotide ATG - CAM2029 CAM2029 -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) 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 Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events From screening to the safety follow-up, assessed up to 6 years Overall response rate 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 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
PFS as assessed by local Investigators 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)
Time to tumor response 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 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
Overall survival 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
Trial Locations
- Locations (98)
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
The Mount Sinai Hospital
🇺🇸Bronx, New York, United States
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