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Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00326469
First received: May 15, 2006
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Neuroendocrine Tumours
 Drug: lanreotide (Autogel formulation)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Ipsen:

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). [ Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24 ] [ Designated as safety issue: No ]

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 [ Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24 ] [ Designated as safety issue: No ]
  • Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel [ Time Frame: Month 3, 6, 9, 12, 18, 21 and 24 ] [ Designated as safety issue: No ]
  • Tolerance [ Time Frame: All visits ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326469

Locations
Spain
H. Juan Canalejo
A Coruña, Spain, 15006
H. Virgen de los Lirios
Alcoy, Spain, 03804
H. General Univ. de Alicante
Alicante, Spain, 03010
H. Germans Trias i Pujol
Badalona, Spain, 08916
H. Santa Creu i Sant Pau
Barcelona, Spain, 08025
Consorci Sanitari de Terrassa
Barcelona, Spain, 08227
Corporación H. Parc Tauli
Barcelona, Spain, 08208
H. Clínic i Provincial
Barcelona, Spain, 08036
H. de Basurto
Bilbao, Spain, 48013
H. General de Elche
Elche, Spain, 03203
H. General de Hospitalet
Llobregat, Spain, 08906
H. Severo Ochoa
Madrid, Spain, 28911
H. 12 de Octubre
Madrid, Spain, 28041
H. Ramón y Cajal
Madrid, Spain, 28034
H. de la Princesa
Madrid, Spain, 28006
H. Clínico Univ. San Carlos
Madrid, Spain, 28040
Fundación H. Son Llàtzer
Palma de Mallorca, Spain, 07198
Consorcio H. de Pontevedre
Pontevedra, Spain, 36001
H. de Sagunto
Puerto de Sagunto, Spain, 46520
H. Clínico de Salamanca
Salamanca, Spain, 37007
Int. Oncológico San Sebastián
San Sebastián, Spain, 20012
H. Marques de Valdecilla
Santander, Spain, 39008
H. Univ. de Canarias
Tenerife, Spain, 38320
H. La Fe
Valencia, Spain, 46009
Hospital Universitario "Dr. Peset"
Valencia, Spain, 446017
H. Hospital General Universitario de Valencia
Valencia, Spain, 46014
H. Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Eva Pineda, MD Ipsen
  More Information

No publications provided

Responsible Party: Eva Pineda, Ipsen
ClinicalTrials.gov Identifier: NCT00326469     History of Changes
Other Study ID Numbers: A-92-52030-166
Study First Received: May 15, 2006
Last Updated: November 30, 2010
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013