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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00353496
First received: July 17, 2006
Last updated: August 29, 2013
Last verified: August 2013
  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)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]
  • Overall survival [ Time Frame: From Week 1 to Death or Last Week of Study ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: June 2006
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lanreotide (Autogel formulation) Drug: lanreotide (Autogel formulation)
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
Placebo Comparator: Placebo Drug: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 71 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Joelle Blumberg, MD Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00353496     History of Changes
Other Study ID Numbers: 2-55-52030-726, 2005-004904-35
Study First Received: July 17, 2006
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration
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: Federal Agency for Medicines and Health Products, FAMHP
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: Medical Products Agency
Italy: Ministry of Health
Austria: Federal Ministry for Health Family and Youth
Slovakia: State Institute for Drug Control

Keywords provided by Ipsen:
Non functioning entero-pancreatic tumours

Additional relevant MeSH terms:
Endocrine Gland Neoplasms
Neoplasms
Adenoma, Islet Cell
Neoplasms by Site
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014