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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002871-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | 120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Juan Canalejo | A Coruña | 15006 | Spain | |||
| H. Virgen de los Lirios |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24053191 | Derived | 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. |
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| Month 3, 6, 9, 12, 18, 21 and 24 |
| Tolerance | All visits |
| Alcoy |
| 03804 |
| Spain |
| H. General Univ. de Alicante | Alicante | 03010 | Spain |
| H. Germans Trias i Pujol | Badalona | 08916 | Spain |
| H. Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| H. Clínic i Provincial | Barcelona | 08036 | Spain |
| Corporación H. Parc Tauli | Barcelona | 08208 | Spain |
| Consorci Sanitari de Terrassa | Barcelona | 08227 | Spain |
| H. General de Hospitalet | Barcelona | 08906 | Spain |
| H. de Basurto | Bilbao | 48013 | Spain |
| H. General de Elche | Elche | 03203 | Spain |
| H. de la Princesa | Madrid | 28006 | Spain |
| H. Ramón y Cajal | Madrid | 28034 | Spain |
| H. Clínico Univ. San Carlos | Madrid | 28040 | Spain |
| H. 12 de Octubre | Madrid | 28041 | Spain |
| H. Severo Ochoa | Madrid | 28911 | Spain |
| Fundación H. Son Llàtzer | Palma de Mallorca | 07198 | Spain |
| Consorcio H. de Pontevedre | Pontevedra | 36001 | Spain |
| H. de Sagunto | Sagunto | 46520 | Spain |
| H. Clínico de Salamanca | Salamanca | 37007 | Spain |
| Int. Oncológico San Sebastián | San Sebastián | 20012 | Spain |
| H. Univ. de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| H. Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario "Dr. Peset" | Valencia | 446017 | Spain |
| H. La Fe | Valencia | 46009 | Spain |
| H. Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| H. Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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