Open label extension study of lanreotide Autogel 120 mg in patientswith non functioning entero-pancreatic endocrine tumour - ND

• Conditions: non functioning entero pancreatic neuro endocrinetumours; MedDRA version: 12.1Level: LLTClassification code 10052399Term: Neuroendocrine tumour

• Registration Number: EUCTR2008-004019-36-IT
• Lead Sponsor: BEAUFOUR IPSEN PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-26
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1) Has provided written informed consent prior to any study-related
procedures.
2) Has 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 two years of participation i.e no code break at
Week 96).
or
- Has received at least one injection in Study 2-55-52030-726 and
had a disease progression, confirmed by central assessment,
during the course of the study and code break showed a placebo
arm.
3) Has a World Health Organisation (WHO) performance score
lower than or equal to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Has been enrolled and treated in the frame of the 2-55-52030-
726 protocol and had a disease progression during the study and
the code break showed a treatment with lanreotide Autogel
120mg.
2) Has received any new treatment for the entero pancreatic neuro
endocrine tumour since the end of participation in the 2-55-
52030-726 study.
3) Is likely to require any additional concomitant treatment to
lanreotide Autogel 120mg for the entero pancreatic neuroendocrine
tumour.
4) Has been treated with radionuclide at any time prior to study entry
5) Has a history of hypersensitivity to drugs with a similar chemical
structure to lanreotide Autogel 120mg.
6) Is likely to require treatment during the study with drugs that are
not permitted by the study protocol.
7) Is at risk of pregnancy or lactation. Females of childbearing
potential must provide a negative pregnancy test at the start of
study and must be using oral, double barrier or injectable
contraception. Non childbearing potential is defined as postmenopause
for at least 1 year, surgical sterilisation or
hysterectomy at least three months before the start of the study.
8) Has 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) Has abnormal findings at Visit 1, any other medical condition(s)
or laboratory findings that, in the opinion of the investigator,
might jeopardise the patients safety or decrease the chance of
obtaining satisfactory data needed to achieve the objective(s) of
the study.
10) Has been previously enrolled in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified