Trial purpose
Cancer treatment
Tumor type
Neuroendocrine tumours
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment arms.
In Arm A (Experimental), participants will receive a drug called CAM2029 (also known as octreotide subcutaneous depot) at a dose of 20mg, administered every 2 weeks as an injection under the skin.
In Arm B (Active Comparator), participants will receive either Octreotide LAR, administered at a dose of 30mg every 4 weeks as an injection into the muscle, or Lanreotide ATG, administered at a dose of 120mg every 4 weeks as a deep injection under the skin.
Conditions
This trial is treating people with gastro-enteropancreatic neuroendocrine tumour (GEP-NET)
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Camurus AB
Scientific Title
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
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