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

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

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.

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.