Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
Condition: Non Functioning Entero-pancreatic Endocrine Tumour
MeSH terms: Endocrine Gland Neoplasms; Adenoma, Islet Cell
Intervention: lanreotide (Autogel formulation)
Intervention description: Autogel 120 mg
Intervention MeSH terms: Lanreotide; Somatostatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lanreotide; Somatuline; Neuroendocrine tumour; NET

Summary:

      The primary purpose of this extension study was to assess the long term safety of patients
      with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open
      label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study,
      2-55-52030-726 (NCT00353496).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Had provided written informed consent prior to any study-related procedures.

          2. Had been enrolled and treated in Study 2-55-52030-726 and either:

               -  Was stable at 96 weeks of treatment (whatever the treatment received during the 2
                  years of participation, i.e. no code break at Week 96); or,

               -  Had received at least one injection in Study 2-55-52030-726 and had disease
                  progression, confirmed by central assessment, during the course of the study and
                  code break showed placebo.

          3. Had a World Health Organisation (WHO) performance score lower than or equal to 2.

        Exclusion Criteria:

          1. Had been enrolled and treated in the frame of the protocol and had disease progression
             during the study and the code break showed a treatment with lanreotide Autogel 120 mg.

          2. Had received any new treatment for the entero-pancreatic NET since the end of
             participation in the study.

          3. Were likely to require any additional concomitant treatment to lanreotide Autogel 120
             mg for the entero-pancreatic NET.

          4. Had been treated with radionuclide at any time prior to study entry.

          5. Had a history of hypersensitivity to drugs with a similar chemical structure to
             lanreotide Autogel 120 mg.

          6. Were likely to require treatment during the study with drugs that were not permitted
             by the study protocol.

          7. Were at risk of pregnancy or lactation. Females of childbearing potential had to
             provide a negative pregnancy test at the start of study and had to be using oral,
             double barrier or injectable contraception. Non-childbearing potential was defined as
             postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least
             3 months before the start of the study.

          8. Had any mental condition rendering the patient unable to understand the nature, scope
             and possible consequences of the study, and/or evidence of an uncooperative attitude.

          9. Had abnormal findings at Visit 1, any other medical condition(s) or laboratory
             findings that, in the opinion of the investigator, might have jeopardised the
             patient's safety or decreased the chance of obtaining satisfactory data needed to
             achieve the objective(s) of the study.

         10. Previous enrolment in this study.