Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
NCT ID: NCT00326469
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2006-05-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Interventions
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lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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
H. Santa Creu i Sant Pau
Barcelona, , Spain
H. Clínic i Provincial
Barcelona, , Spain
Corporación H. Parc Tauli
Barcelona, , Spain
Consorci Sanitari de Terrassa
Barcelona, , Spain
H. General de Hospitalet
Barcelona, , Spain
H. de Basurto
Bilbao, , Spain
H. General de Elche
Elche, , Spain
H. de la Princesa
Madrid, , Spain
H. Ramón y Cajal
Madrid, , Spain
H. Clínico Univ. San Carlos
Madrid, , Spain
H. 12 de Octubre
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. Univ. de Canarias
Santa Cruz de Tenerife, , Spain
H. Marques de Valdecilla
Santander, , Spain
Hospital Universitario "Dr. Peset"
Valencia, , Spain
H. La Fe
Valencia, , Spain
H. Hospital General Universitario de Valencia
Valencia, , Spain
H. Miguel Servet
Zaragoza, , Spain
Countries
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References
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Martin-Richard M, Massuti B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galan A, Llanos M, Sala MA, Pericay C, Rivera F, Sastre J, Segura A, Quindos M, Maisonobe P; TTD (Tumores del Tracto Digestivo) Study Group. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study. BMC Cancer. 2013 Sep 20;13:427. doi: 10.1186/1471-2407-13-427.
Other Identifiers
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2004-002871-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A-92-52030-166
Identifier Type: -
Identifier Source: org_study_id