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

Ipsen

Status and phase

Completed

Phase 2

Conditions

Neuroendocrine Tumours

Treatments

Drug: lanreotide (Autogel formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00326469

2004-002871-18 (EudraCT Number)

A-92-52030-166

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.