Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)
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|ClinicalTrials.gov Identifier: NCT00842348|
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : February 17, 2017
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Functioning Entero-pancreatic Endocrine Tumour||Drug: lanreotide (Autogel formulation)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Lanreotide (Autogel formulation)
Patients from the preceding DB study (Study 726) were treated with open label lanreotide Autogel 120 mg by deep subcutaneous injections every 28 days. Patients were included if they had been treated with lanreotide (Autogel formulation) or placebo in DB Study 726 and had stable disease at the end of the 96-week treatment period, or if they had received placebo and had disease progression at any time during Study 726. Safety data were based on the safety population patients who received lanreotide in Study 729). The main efficacy analysis was based on the ITT population (patients randomised in Study 726 regardless of whether they continued into Study 729).
Drug: lanreotide (Autogel formulation)
Autogel 120 mg
- Adverse Events [ Time Frame: Throughout the study until the completion/early discontinuation visit. ]
Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.
An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:
- It was not present prior to receiving the first dose of study treatment in Study 729; or,
- It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.
Adverse event data are presented in the AE section.
- Progression Free Survival (PFS): Kaplan-Meier Estimate [ Time Frame: Throughout the study (every 24 weeks and at completion/withdrawal visit) ]
The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.
Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842348
|Study Director:||Ipsen Medical Director||Ipsen|