Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine … (NCT00842348) | Clinical Trial Compass
CompletedPhase 3
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
United States, Belgium, Czechia89 participantsStarted 2009-02
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Had provided written informed consent prior to any study-related procedures.
✓. Had been enrolled and treated in Study 2-55-52030-726 and either:
✓. Had a World Health Organisation (WHO) performance score lower than or equal to 2.
Exclusion criteria
✕. 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.
What they're measuring
1
Adverse Events
Timeframe: Throughout the study until the completion/early discontinuation visit.
. 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.