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Open Label Extension Study of Lanreotide Autogel 120mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour


Phase 3
18 Years
N/A
Open (Enrolling by invite only)
Male
Non Functioning Entero-pancreatic Endocrine Tumour

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Trial Information

Open Label Extension Study of Lanreotide Autogel 120mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour


Inclusion Criteria:

-

- Has provided written informed consent prior to any study-related procedures

- Has been enrolled and treated in Study 2-55-52030-726 and either:

1. Was stable at 96 weeks of treatment or

2. Has received at least one injection in Study 2-55-52030-726 and had a disease
progression and was in the placebo arm

- Has a World Health Organisation (WHO) performance score lower than or equal to 2

Exclusion Criteria:

- Has been enrolled and treated in the frame of the 2-55-52030-726 protocol and had a
disease progression when receiving lanreotide Autogel 120mg

- Has received any new treatment for the entero-pancreatic neuroendocrine tumour since
the end of participation in the 2-55-52030-726 study

- Is likely to require any additional concomitant treatment to lanreotide Autogel 120mg
for the entero-pancreatic neuro-endocrine tumour

- Has a history of hypersensitivity to drugs with a similar chemical structure to
lanreotide Autogel 120mg

- Has been treated with radionuclide at any time prior to study entry

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

adverse events

Outcome Time Frame:

throughout study

Safety Issue:

Yes

Principal Investigator

Joelle Blumberg, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2-55-52030-729

NCT ID:

NCT00842348

Start Date:

September 2008

Completion Date:

December 2016

Related Keywords:

  • Non Functioning Entero-pancreatic Endocrine Tumour
  • Endocrine Gland Neoplasms
  • Adenoma, Islet Cell

Name

Location

Ceders-Sinai Outpatient Cancer CenterLos Angeles, California  90048
The John Hopkins HospitalBaltimore, Maryland  21287-4606