A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NET

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

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)
• Results from FDG-PET CT for patients with well-differentiated Grade 3 NET (if performed) must show that FDG avid areas of disease also are avid on somatostatin-receptor imaging
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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 (where 1 cycle means =28 days on treatment) of targeted therapies such as mTOR inhibitors (e.g. sirolimus, temsirolimus, or everolimus) or vascular endothelial growth factor inhibitors (e.g. sunitinib, lenvatinib, or cabozantinib), 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
• Hepatic/pancreatic-related exclusion criteria:
a) Active hepatitis. Patients with no significant viral load, no acute signs of inflammation, and no clinical necessity for therapy are allowed, at the Investigator’s discretion
b) Symptomatic cholelithiasis
c) Clinically active or chronic liver disease, including liver cirrhosis of Child-Pugh class B or C
• Patients with poorly controlled diabetes, as evidenced by hemoglobin A1c (HbA1c) >8.0%
• Cardiac history or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following:
a )History of myocardial infarction, unstable angina pectoris, or coronary artery bypass graft within 6 months before screening
b) Uncontrolled congestive heart failure
• Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, or high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II, and third-degree atrioventricular block)
• Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
a) Risk factors for Torsades de Pointes, including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
b) Treatment with concomitant medication(s) with a known risk of Torsades de Pointes” per www.crediblemeds.org that cannot be discontinued or replaced with safe alternative medication at least 7 days or 5 half-lives (whichever is longer) before start of IMP treatment
c) Patients with a baseline QTc interval corrected by Fridericia’s formula (QTcF) >450 msec for males and >470 msec for females at screening
• Any other contraindicated serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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