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: February 18, 2015
Last verified: February 2015
  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:
  • Progression-Free Survival (PFS) [ Time Frame: From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year ] [ Designated as safety issue: No ]
    Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0


Secondary Outcome Measures:
  • Percentage of Patients Alive & Without Disease Progression [ Time Frame: Week 48 & 96 ] [ Designated as safety issue: No ]
    Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.

  • Pharmacokinetic Profile of Lanreotide [ Time Frame: Week 4, 12, 24, 36, 48, 72, 96 ] [ Designated as safety issue: No ]
    Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints

  • Change in the Global Health Status Quality of Life Assessment [ Time Frame: Week 12 to Week 96 (last visit) ] [ Designated as safety issue: No ]
    Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.

  • Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels [ Time Frame: Week 12 to Week 96 (last visit) ] [ Designated as safety issue: No ]
  • Percentage of Patients Still Alive Based on Available Overall Survival Data [ Time Frame: Randomisation to death or last visit, up to 321 weeks ] [ Designated as safety issue: No ]
    Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.


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 96 weeks.
Placebo Comparator: Placebo Drug: Placebo
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

  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: Medical Director, Endocrinology Ipsen
  More Information

Publications:
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
Results First Received: January 15, 2015
Last Updated: February 18, 2015
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
India: Drugs Controller General of India

Keywords provided by Ipsen:
Non functioning entero-pancreatic tumours

Additional relevant MeSH terms:
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Apudoma
Carcinoid Tumor
Neuroendocrine Tumors
Adenocarcinoma
Adenoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Pancreatic Diseases
Pancreatic Neoplasms
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2015