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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: lanreotide (Autogel formulation)
  • 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
• Drug: Placebo
  • Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: lanreotide (Autogel formulation)
• Placebo Comparator: Placebo

Primary Measures

• Time to either disease progression or death
  • Time Frame: Within 96 weeks after the first study drug administration
    Safety Issue?: No

Secondary Measures

• Proportion of patients alive & without progression
  • Time Frame: Week 48 & 96
    Safety Issue?: No
• Side effects
  • Time Frame: For the duration of the study
    Safety Issue?: Yes
• Pharmacokinetic profile of lanreotide
  • Time Frame: Week 1,4, 12, 20, 24, 36, 48, 72, 96
    Safety Issue?: No
• Quality of life
  • Time Frame: At every visit (excluding screening)
    Safety Issue?: No
• Tumour markers
  • Time Frame: At every visit (excluding screening)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Ipsen Industry

Overall Clinical Trial Officials and Contacts

Joelle Blumberg, MD Study Director Ipsen  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00353496

Study ID Number: 2-55-52030-726

ClinicalTrials.gov Identifier: NCT00353496

Health Authority: United States: Food and Drug Administration