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Trial record 7 of 37 for:    Lanreotide | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00326469
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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
Neuroendocrine Tumours Drug: lanreotide (Autogel formulation) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
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 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009


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.




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). [ Time Frame: 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 [ Time Frame: Month 3, 6, 9, 12, 15, 18, 21 and 24 ]
  2. Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel [ Time Frame: Month 3, 6, 9, 12, 18, 21 and 24 ]
  3. Tolerance [ Time Frame: All visits ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326469


Locations
Show Show 27 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00326469    
Other Study ID Numbers: A-92-52030-166
2004-002871-18 ( EudraCT Number )
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Lanreotide
Angiopeptin
Antineoplastic Agents