Status:
COMPLETED
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Lead Sponsor:
Ipsen
Conditions:
Endocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00353496
Start Date
June 1 2006
End Date
April 1 2013
Last Update
March 5 2025
Active Locations (71)
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1
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
The John Hopkins Hospital
Baltimore, Maryland, United States, 21287-4606
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115