Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours (CLARINET)
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|ClinicalTrials.gov Identifier: NCT00353496|
Recruitment Status : Completed
First Posted : July 18, 2006
Results First Posted : February 18, 2015
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Endocrine Tumors||Drug: lanreotide (Autogel formulation) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
|Experimental: lanreotide (Autogel formulation)||
Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
|Placebo Comparator: Placebo||
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
- Progression-Free Survival (PFS) [ Time Frame: From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year ]Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0
- Percentage of Patients Alive & Without Disease Progression [ Time Frame: Week 48 & 96 ]Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
- Pharmacokinetic Profile of Lanreotide [ Time Frame: Week 4, 12, 24, 36, 48, 72, 96 ]Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
- Change in the Global Health Status Quality of Life Assessment [ Time Frame: Week 12 to Week 96 (last visit) ]Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.
- Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels [ Time Frame: Week 12 to Week 96 (last visit) ]
- Percentage of Patients Still Alive Based on Available Overall Survival Data [ Time Frame: Randomisation to death or last visit, up to 321 weeks ]Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.
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): NCT00353496
|Study Director:||Medical Director, Endocrinology||Ipsen|