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

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00326469
Collaborator
(none)
30
Enrollment
27
Locations
1
Arm
42.1
Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: lanreotide (Autogel formulation)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. 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]

  2. Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel [Month 3, 6, 9, 12, 18, 21 and 24]

  3. Tolerance [All visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
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
5 H. Santa Creu i Sant Pau Barcelona Spain 08025
6 H. Clínic i Provincial Barcelona Spain 08036
7 Corporación H. Parc Tauli Barcelona Spain 08208
8 Consorci Sanitari de Terrassa Barcelona Spain 08227
9 H. General de Hospitalet Barcelona Spain 08906
10 H. de Basurto Bilbao Spain 48013
11 H. General de Elche Elche Spain 03203
12 H. de la Princesa Madrid Spain 28006
13 H. Ramón y Cajal Madrid Spain 28034
14 H. Clínico Univ. San Carlos Madrid Spain 28040
15 H. 12 de Octubre Madrid Spain 28041
16 H. Severo Ochoa Madrid Spain 28911
17 Fundación H. Son Llàtzer Palma de Mallorca Spain 07198
18 Consorcio H. de Pontevedre Pontevedra Spain 36001
19 H. de Sagunto Sagunto Spain 46520
20 H. Clínico de Salamanca Salamanca Spain 37007
21 Int. Oncológico San Sebastián San Sebastián Spain 20012
22 H. Marques de Valdecilla Santander Spain 39008
23 H. Univ. de Canarias Tenerife Spain 38320
24 Hospital Universitario "Dr. Peset" Valencia Spain 446017
25 H. La Fe Valencia Spain 46009
26 H. Hospital General Universitario de Valencia Valencia Spain 46014
27 H. Miguel Servet Zaragoza Spain 50009

Sponsors and Collaborators

  • Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00326469
Other Study ID Numbers:
  • A-92-52030-166
  • 2004-002871-18
First Posted:
May 16, 2006
Last Update Posted:
Nov 5, 2020
Last Verified:
Nov 1, 2020
Additional relevant MeSH terms:
Neuroendocrine Tumors
Lanreotide

Study Results

No Results Posted as of Nov 5, 2020