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
Key Inclusion Criteria
Key Exclusion Criteria
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.
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
Trial Location Name
Fiona Stanley Hospital (Oncology)
11 Robin Warren Dr, Murdoch WA 6150, Australia
Primary Contact :
, (08) 6152 6530
Secondary Contact :
Treatment - Drugs
By Self-Referral,By Specialist and/or Surgeon Referral,Primary Care or GP Referral
Mutation Status and Biomarker
Any or not stated
Is it a Cohort Trial?
Is this a Tele-Trial?
Can healthy volunteer participate?