Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

Study Overview
=================
Brief Summary
-----------------
To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.

Official Title
-----------------
Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel Administered Every 4 Weeks by Deep Subcutaneous Injection in the Tumour's Growth Stabilization of Patients With Progressive Neuroendocrine Tumours Who Are Not Eligible to be Treated With Either Surgery or Chemotherapy

Conditions
-----------------
Neuroendocrine Tumours

Intervention / Treatment
-----------------
* Drug: lanreotide (Autogel formulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease patients with progressive disease in the previous 6 months before their inclusion in the study patients with positive IN111 octreotide scintigraphy Exclusion Criteria: patients with surgically removable localised disease patients with progressive disease in the first six months of being diagnosed patients with intestinal obstruction due to a carcinoid tumour patients who have received treatment with somatostatin analogues during the 6 months before being included in the study patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: lanreotide (Autogel formulation)<br>* 120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study). |  | Month 3, 6, 9, 12, 15, 18, 21 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy related to tumour's partial or total response, biological disease markers response, symptomatic control, effect of treatment on patient's quality of life |  | Month 3, 6, 9, 12, 15, 18, 21 and 24 | 
| Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel |  | Month 3, 6, 9, 12, 18, 21 and 24 | 
| Tolerance |  | All visits |