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

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

August 27, 2009

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Time to either disease progression or death within 96 weeks after the first study drug administration.

Change History

Complete list of historical versions of study NCT00353496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To compare the effect of lanreotide Autogel and placebo on the time to progression, quality of life and on tumour markers
Side effects of the treatment will be assessed
Pharmacokinetic profile of lanreotide will be assessed.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Endocrine Tumors

Intervention ^ICMJE

Drug: lanreotide (Autogel formulation)
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00353496

Responsible Party

Joelle Blumberg, Ipsen

Study ID Numbers ^ICMJE

2-55-52030-726

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Joelle Blumberg, MD

Ipsen

Information Provided By

Ipsen

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP