NCT05050942
Active, not recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Camurus AB
- Enrollment
- 332
- Locations
- 98
- Primary Endpoint
- Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CAM2029
Experimental
Intervention: CAM2029 (Drug)
Octreotide LAR or lanreotide ATG
Active Comparator
Intervention: Octreotide LAR (Drug)
Octreotide LAR or lanreotide ATG
Active Comparator
Intervention: Lanreotide ATG (Drug)
Outcomes
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
- 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)
- Disease control rate(From date of randomization until disease progression, assessed up to 48 months)
- 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)
- Time to tumor response(From date of randomization until disease progression, assessed up to 48 months)
- Duration of response(From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months)
- Overall survival(Up to 2 years following the primary efficacy analysis)
Investigators
Study Sites (98)
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