Status:
COMPLETED
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
Lead Sponsor:
Ipsen
Conditions:
Non Functioning Entero-pancreatic Endocrine Tumour
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international cou...
Eligibility Criteria
Inclusion
- Had provided written informed consent prior to any study-related procedures.
- 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.
- Had a World Health Organisation (WHO) performance score lower than or equal to 2.
Exclusion
- 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.
- Had received any new treatment for the entero-pancreatic NET since the end of participation in the study.
- Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET.
- Had been treated with radionuclide at any time prior to study entry.
- Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg.
- Were likely to require treatment during the study with drugs that were not permitted by the study protocol.
- 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.
- 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.
- 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.
- Previous enrolment in this study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00842348
Start Date
February 1 2009
End Date
December 1 2015
Last Update
October 12 2022
Active Locations (25)
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1
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
2
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-4606
3
UZ Antwerpen
Antwerp, Belgium
4
UCL Saint Luc
Brussels, Belgium