A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

• Status: Terminated
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

Inclusion Criteria:

• Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)

• Progressive before first-line treatment

• Histologically confirmed (either on primary tumour or metastases)

• Pathological diagnosis validated by the NET consulting pathologist

• Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation

• The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy

• Non-functional tumour or gastrinoma controlled by PPIs

• Age > or = 18 years

• WHO 0, 1 or 2

• Effective contraception for male or female patients of childbearing age, defined as:

oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.

• Signed informed consent prior to initiation of any study-specific procedures or treatment.

Exclusion Criteria:

• History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)

• Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 > 20%)

• If primary resected, bone metastasis exclusively

• Pre-treatment by somatostatin long-acting analogue

• Total bilirubin ≥ 60 µmol/L

• Uncontrolled diabetes

• Contraindication to product used in the study or its components

• Tumour arising in the context of a genetic disease

• Pregnancy or lactation

• Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons

• Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.