Back to resultsEfficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
Primary Purpose
Neuroendocrine Tumours
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
lanreotide (Autogel formulation)
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumours
Eligibility Criteria
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.
Sites / Locations
- H. Juan Canalejo
- H. Virgen de los Lirios
- H. General Univ. de Alicante
- H. Germans Trias i Pujol
- H. Santa Creu i Sant Pau
- H. Clínic i Provincial
- Corporación H. Parc Tauli
- Consorci Sanitari de Terrassa
- H. General de Hospitalet
- H. de Basurto
- H. General de Elche
- H. de la Princesa
- H. Ramón y Cajal
- H. Clínico Univ. San Carlos
- H. 12 de Octubre
- H. Severo Ochoa
- Fundación H. Son Llàtzer
- Consorcio H. de Pontevedre
- H. de Sagunto
- H. Clínico de Salamanca
- Int. Oncológico San Sebastián
- H. Marques de Valdecilla
- H. Univ. de Canarias
- Hospital Universitario "Dr. Peset"
- H. La Fe
- H. Hospital General Universitario de Valencia
- H. Miguel Servet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel
Tolerance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00326469
Brief Title
Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumours
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lanreotide (Autogel formulation)
Intervention Description
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Primary Outcome Measure Information:
Title
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).
Time Frame
Month 3, 6, 9, 12, 15, 18, 21 and 24
Secondary Outcome Measure Information:
Title
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
Time Frame
Month 3, 6, 9, 12, 15, 18, 21 and 24
Title
Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel
Time Frame
Month 3, 6, 9, 12, 18, 21 and 24
Title
Tolerance
Time Frame
All visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
H. Juan Canalejo
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
H. Virgen de los Lirios
City
Alcoy
ZIP/Postal Code
03804
Country
Spain
Facility Name
H. General Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
H. Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
H. Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
H. Clínic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Corporación H. Parc Tauli
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Consorci Sanitari de Terrassa
City
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
H. General de Hospitalet
City
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
H. de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
H. General de Elche
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
H. de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
H. Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
H. Clínico Univ. San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
H. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
H. Severo Ochoa
City
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Fundación H. Son Llàtzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Consorcio H. de Pontevedre
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
H. de Sagunto
City
Sagunto
ZIP/Postal Code
46520
Country
Spain
Facility Name
H. Clínico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Int. Oncológico San Sebastián
City
San Sebastián
ZIP/Postal Code
20012
Country
Spain
Facility Name
H. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
H. Univ. de Canarias
City
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario "Dr. Peset"
City
Valencia
ZIP/Postal Code
446017
Country
Spain
Facility Name
H. La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
H. Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
H. Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24053191
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
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