Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
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
2 other identifiers
interventional
30
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2006
Typical duration for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 5, 2020
November 1, 2020
3.5 years
May 15, 2006
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Month 3, 6, 9, 12, 18, 21 and 24
Tolerance
All visits
Study Arms (1)
1
EXPERIMENTALInterventions
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
Eligibility Criteria
You may qualify if:
- 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 positive IN111 octreotide scintigraphy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (27)
H. Juan Canalejo
A Coruña, 15006, Spain
H. Virgen de los Lirios
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
Related Publications (1)
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.
PMID: 24053191DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2006
First Posted
May 16, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 5, 2020
Record last verified: 2020-11