Study of Lanreotide Autogel in Non-Functioning Entero-Pancreatic Endocrine Tumours - Full Text View

Purpose

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.

Condition	Intervention	Phase
Endocrine Tumors	Drug: lanreotide (Autogel formulation) Other: Placebo	Phase III

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Sodium chloride Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Ipsen:

Primary Outcome Measures:

Time to either disease progression or death [ Time Frame: Within 96 weeks after the first study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: lanreotide (Autogel formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
2: Placebo Comparator	Other: Placebo Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353496

Contacts


Contact: Ipsen Recruitment Enquiries		clinical.trials@ipsen.com

Show 50 Study Locations

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	Catherine Lesage, MD	Ipsen

More Information

Responsible Party:	Ipsen ( Catherine Lesage )
Study ID Numbers:	2-55-52030-726
First Received:	July 17, 2006
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00353496
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: Directorate general for the protection of Public health: Medicines; Spain: Spanish Agency of Medicines; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health; Greece: Ministry of Health and Welfare; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Sweden: Ministry of Health and Social Affairs; Italy: Ministry of Health; Austria: Ministry of Health

Keywords provided by Ipsen:

Non functioning entero-pancreatic tumours

Study placed in the following topic categories:

Digestive System Neoplasms

Pancreatic Neoplasms

Disease Progression

Angiopeptin

Endocrine System Diseases

Adenoma, Islet Cell

Lanreotide

Digestive System Diseases

Gastrointestinal Neoplasms

Pancreatic Diseases

Endocrinopathy

Adenoma

Endocrine Gland Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 08, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00353496