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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Endocrine Tumors

Treatments: Drug: Placebo; Drug: lanreotide (Autogel formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353496

2-55-52030-726

2005-004904-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 2 patient groups, including a placebo group

lanreotide (Autogel formulation)

Experimental group

Treatment:

Drug: lanreotide (Autogel formulation)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo