CompletedPhase 3

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

United States264 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Progression-Free Survival (PFS)

Timeframe: 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

Trial details

NCT IDNCT00353496

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2015-01-15

View on ClinicalTrials.gov More Endocrine Tumors trials