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Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
This study is currently recruiting participants.
Study NCT00353496   Information provided by Ipsen
First Received: July 17, 2006   Last Updated: August 27, 2009   History of Changes

July 17, 2006
August 27, 2009
June 2006
June 2012   (final data collection date for 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 ]
Time to either disease progression or death within 96 weeks after the first study drug administration.
Complete list of historical versions of study NCT00353496 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
 
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Endocrine Tumors
  • Drug: lanreotide (Autogel formulation)
  • Other: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
United States,   Austria,   Belgium,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Slovakia,   Spain,   Sweden,   United Kingdom
 
NCT00353496
Joelle Blumberg, Ipsen
2-55-52030-726
Ipsen
 
Study Director: Joelle Blumberg, MD Ipsen
Ipsen
August 2009

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