Skip to main content
OpenTrials
Completed

NCT Number: NCT00326469

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuroendocrine Tumours Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H. Juan Canalejo, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lanreotide (Autogel formulation)

Drug

120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

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).

    Time frame: Month 3, 6, 9, 12, 15, 18, 21 and 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 16, 2006
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.