Gastro-enteropancreatic Neuroendocrine Tumor
Conditions
Keywords
CAM2029, GEP-NET, Octreotide, SORENTO
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.
Interventions
DRUGCAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
DRUGOctreotide LAR
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection
DRUGLanreotide ATG
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection
Sponsors
Camurus AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | From screening to the safety follow-up, assessed up to 6 years | — |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Romania, Spain, United States
Outcome results
None listed