Feasibility study to assess safety of high dose of lanreotide in net patients poorly controlled by standard doses of SSA

Phase 1

• Conditions: euroendocrine tumours; MedDRA version: 14.1Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-005222-30-IT
• Lead Sponsor: IVERSITA' DI GENOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Subjects of both gender, aged =18 years AND = 75 years 2) patients with histological diagnosis of WD NETs, defined according to the recent WHO classification for gastroentero pancreatic (WHO 2010), bronchial and thymic NET(WHO 2004) or with hepatic metastases documented through a bioptic exam and Occult Primary tumor; patient with or without carcinoid syndrome could be enrolled; 3) Patients on treatment with standard dosages of octreotide LAR (30 mg/28 days) or lanreotide Autogel (120 mg/28 days) in the 6 months before enrollment; 4) Patients with tumor/biochemical/ symptomatic disease progression 5) Urine negative pregnancy test for women of childbearing age. Female subjects of childbearing potential must be using an appropriate method of contraception like double-barrier contraception , oral estroprogestinic contraceptive or an intrauterine device (IUD). Patient must be willing to continue using it throughout the entire study period, until two month after the study end; if the patient is a man, if the partner is a childbearing potential female, he should agree to using appropriate method of contraception;
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. patients initially not responsive to SSA 2. patient naive to any treatment to SSA analogues 3. stable disease on treatment with SSA at standard dosages; 4. previous surgical treatment for NET in the 4 weeks before enrollment or planned during the study; 5. symptomatic colelitiasis 6. unstable angina, supported ventricular tachycardia, ventricular fibrillation, myocardial infarction in three months before enrollment; 7. hepatic disease here included cirrhosis, chronic or active hepatitis, permanent increase of AST, ALT, alkaline phosphatase 2xULN (upper limit normal) or increase of AST, ALT, alkaline phosphatase 4xULN (upper limit normal) in patients with hepatic metastases, total bilirubin 1.5xULN or creatinine 1.5xULN; 8. Specific previous antitumor treatment, here included, chemotherapy, chemoembolization, radiotherapy, PRRT or interferon in the 6 months before enrollment or planned during the study (based in investigator judgment) 9. Previous neoplastic disease (excepted basal cell carcinoma, cervical carcinoma in situ or uterine cancer, thyroid microcarcinoma or thyroid and prostate carcinoma surgically eradicated). Patients with carcinoma diagnosis can be enrolled in the study only if treated with a curative intent and free from disease from at least 5 years; 10. Decompensated diabetes mellitus (HbA1c> 8%); 11. Pregnant or breast-feeding women; Female subjects of childbearing potential not using an appropriate anticonceptive method 12. Hypersensitivity to lanreotide 13. Presence of adverse events (grade>1 according to NCI CTCAE (Versione 3.0) criteria) related to SSA treatment at inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study objective is to evaluate the safety of lanreotide 90 mg in double dose (lanreotide 180 mg) every 28 days in patients affected by well differentiated neuroendocrine tumours (WD NETs) with disease progression during standard treatment with SSA (lanreotide 120mg ooctreotide 30mg every 28 days).;Secondary Objective: Secondary study Objectives are efficacy evaluations through tumor, clinical and laboratory parameters.;Primary end point(s): The primary endpoint for safety evaluation, is the patient proportion that has at least a serious adverse event during treatment with lanreotide.;Timepoint(s) of evaluation of this end point: At each visit