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

Phase 2

Completed

• Conditions: Neuroendocrine Tumours
• Interventions: Drug: lanreotide (Autogel formulation)

• Registration Number: NCT00326469
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-16
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lanreotide (Autogel formulation)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (27)

H. General de Elche; 🇪🇸 Elche, Spain

H. Germans Trias i Pujol; 🇪🇸 Badalona, Spain

H. Ramón y Cajal; 🇪🇸 Madrid, Spain

H. Clínico Univ. San Carlos; 🇪🇸 Madrid, Spain

H. Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

H. 12 de Octubre; 🇪🇸 Madrid, Spain

H. Clínic i Provincial; 🇪🇸 Barcelona, Spain

Corporación H. Parc Tauli; 🇪🇸 Barcelona, Spain

Fundación H. Son Llàtzer; 🇪🇸 Palma de Mallorca, Spain

H. de Basurto; 🇪🇸 Bilbao, Spain

H. de Sagunto; 🇪🇸 Sagunto, Spain

H. Clínico de Salamanca; 🇪🇸 Salamanca, Spain

Consorcio H. de Pontevedre; 🇪🇸 Pontevedra, Spain

H. de la Princesa; 🇪🇸 Madrid, Spain

Int. Oncológico San Sebastián; 🇪🇸 San Sebastián, Spain

H. Univ. de Canarias; 🇪🇸 Tenerife, Spain

Hospital Universitario "Dr. Peset"; 🇪🇸 Valencia, Spain

H. Marques de Valdecilla; 🇪🇸 Santander, Spain

H. La Fe; 🇪🇸 Valencia, Spain

H. Miguel Servet; 🇪🇸 Zaragoza, Spain

H. Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

H. Juan Canalejo; 🇪🇸 A Coruña, Spain

H. General Univ. de Alicante; 🇪🇸 Alicante, Spain

H. Virgen de los Lirios; 🇪🇸 Alcoy, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Barcelona, Spain

H. Severo Ochoa; 🇪🇸 Madrid, Spain

H. General de Hospitalet; 🇪🇸 Barcelona, Spain