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

Neuroendocrine Tumours Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326469
• Other study ID #: A-92-52030-166
• Secondary ID: 2004-002871-18
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Est. completion date: November 2009

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Neuroendocrine Tumours

Intervention

Drug:
• lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

Locations

Country	Name	City	State
Spain	H. Juan Canalejo	A Coruña
Spain	H. Virgen de los Lirios	Alcoy
Spain	H. General Univ. de Alicante	Alicante
Spain	H. Germans Trias i Pujol	Badalona
Spain	Consorci Sanitari de Terrassa	Barcelona
Spain	Corporación H. Parc Tauli	Barcelona
Spain	H. Clínic i Provincial	Barcelona
Spain	H. General de Hospitalet	Barcelona
Spain	H. Santa Creu i Sant Pau	Barcelona
Spain	H. de Basurto	Bilbao
Spain	H. General de Elche	Elche
Spain	H. 12 de Octubre	Madrid
Spain	H. Clínico Univ. San Carlos	Madrid
Spain	H. de la Princesa	Madrid
Spain	H. Ramón y Cajal	Madrid
Spain	H. Severo Ochoa	Madrid
Spain	Fundación H. Son Llàtzer	Palma de Mallorca
Spain	Consorcio H. de Pontevedre	Pontevedra
Spain	H. de Sagunto	Sagunto
Spain	H. Clínico de Salamanca	Salamanca
Spain	Int. Oncológico San Sebastián	San Sebastián
Spain	H. Marques de Valdecilla	Santander
Spain	H. Univ. de Canarias	Tenerife
Spain	H. Hospital General Universitario de Valencia	Valencia
Spain	H. La Fe	Valencia
Spain	Hospital Universitario "Dr. Peset"	Valencia
Spain	H. Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel		Month 3, 6, 9, 12, 18, 21 and 24
Secondary	Tolerance		All visits