Status:
COMPLETED
Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
Lead Sponsor:
Ipsen
Conditions:
Neuroendocrine Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Aut...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00326469
Start Date
May 1 2006
End Date
November 1 2009
Last Update
November 5 2020
Active Locations (27)
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1
H. Juan Canalejo
A Coruña, Spain, 15006
2
H. Virgen de los Lirios
Alcoy, Spain, 03804
3
H. General Univ. de Alicante
Alicante, Spain, 03010
4
H. Germans Trias i Pujol
Badalona, Spain, 08916