Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

Study Overview
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Brief Summary
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The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

Official Title
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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

Conditions
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Endocrine Tumors

Intervention / Treatment
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* Drug: lanreotide (Autogel formulation)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease No hormone related symptoms Well or moderately differentiated tumour confirmed by histology Tumour lesions which are measurable by a CT or MRI scan Exclusion Criteria: Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years Pregnant or lactating Females must use adequate contraception during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lanreotide (Autogel formulation)<br> | Drug: lanreotide (Autogel formulation)<br>* 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Alive & Without Disease Progression | Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96. | Week 48 & 96 | 
| Pharmacokinetic Profile of Lanreotide | Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints | Week 4, 12, 24, 36, 48, 72, 96 | 
| Change in the Global Health Status Quality of Life Assessment | 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. | Week 12 to Week 96 (last visit) | 
| Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels |  | Week 12 to Week 96 (last visit) | 
| Percentage of Patients Still Alive Based on Available Overall Survival Data | 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. | Randomisation to death or last visit, up to 321 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non functioning entero-pancreatic tumours