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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Tumours

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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).

Outcome Time Frame:

Month 3, 6, 9, 12, 15, 18, 21 and 24

Safety Issue:

No

Principal Investigator

Eva Pineda, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Spain: Ministry of Health

Study ID:

A-92-52030-166

NCT ID:

NCT00326469

Start Date:

May 2006

Completion Date:

November 2009

Related Keywords:

  • Neuroendocrine Tumours
  • Neuroendocrine Tumors

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