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

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

This study is currently recruiting participants.

Study NCT00353496. Last updated on October 21, 2008. Information provided by Ipsen

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Endocrine Tumors

Intervention ^†

Drug: lanreotide (Autogel formulation)
Other: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

200

Start Date ^†

June 2006

Completion Date

June 2011

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Location Countries ^†

United States, Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00353496

Organization ID

2-55-52030-726

Secondary IDs ^††

Study Sponsor ^†

Ipsen

Collaborators ^††

Investigators ^†

Study Director:

Catherine Lesage, MD

Ipsen

Information Provided By

Ipsen

Verification Date

October 2008

First Received Date ^†

July 17, 2006

Last Updated Date

October 21, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.