Clinical trial Of Lanreotide Autogel 120 Mg In Patients With Non Functioning Entero-Pancreatic Endocrine Tumour
- Conditions
- Health Condition 1: null- Non functioning entero-pancreatic endocrine tumour
- Registration Number
- CTRI/2012/09/003010
- Lead Sponsor
- IPSEN PHARMA SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
All patients must fulfil the following:
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.
Patients will not be included in the study if the patient :
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 neuroendocrine 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 120 mg.
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 post-menopause 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 patientâ??s 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method long term safety of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero pancreatic neuroendocrine tumour.Timepoint: 96 weeks
- Secondary Outcome Measures
Name Time Method the long term efficacy of administration of lanreotide Autogel 120 mg every 28 days in patients with non functioning entero pancreatic neuroendocrine tumours.Timepoint: 96 weeks