| Study of Lanreotide Autogel in Non-Functioning Entero-Pancreatic Endocrine Tumours |
| 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 |
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. |
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| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Time to either disease progression or death [ Time Frame: Within 96 weeks after the first study drug administration ] [ Designated as safety issue: No ] |
Proportion of patients alive & without progression [ Time Frame: Week 48 & 96 ] [ Designated as safety issue: No ]
Side effects [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]
Pharmacokinetic profile of lanreotide [ Time Frame: Week 1,4, 12, 20, 24, 36, 48, 72, 96 ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: At every visit (excluding screening) ] [ Designated as safety issue: No ]
Tumour markers [ Time Frame: At every visit (excluding screening) ] [ Designated as safety issue: No ] |
| Endocrine Tumors |
Drug: lanreotide (Autogel formulation)
Other: Placebo |
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| Recruiting |
| 200 |
| June 2006 |
| June 2011 |
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
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| Both |
| 18 Years and older |
| No |
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| United States, Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom |
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| NCT00353496 |
| 2-55-52030-726 |
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| Ipsen |
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| Study Director: |
Catherine Lesage, MD |
Ipsen |
|
|
| Ipsen |
| October 2008 |
| July 17, 2006 |
| October 21, 2008 |