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
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Endocrine Tumors
Interventions: Drug: lanreotide (Autogel formulation)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
264 subjects were screened at 48 investigational sites in 14 countries (Austria, Belgium, Czech Republic, Denmark, France, Germany, India, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom and the United States of America). 204 subjects were randomised to receive study treatment in the Intent to treat (ITT) population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lanreotide (Autogel Formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Placebo Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Participant Flow:   Overall Study
    Lanreotide (Autogel Formulation)     Placebo  
STARTED     101     103  
COMPLETED     85 [1]   86  
NOT COMPLETED     16     17  
Adverse Event                 1                 0  
Protocol Violation                 2                 2  
Withdrawal by Subject                 3                 4  
Physician Decision                 6                 9  
Not otherwise specified                 4                 2  
[1] Patients who completed specified assessments or met primary efficacy endpoint criteria for an event.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis based on intent-to-treat (ITT) population comprised of 204 subjects.

Reporting Groups
  Description
Lanreotide (Autogel Formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Placebo Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Total Total of all reporting groups

Baseline Measures
    Lanreotide (Autogel Formulation)     Placebo     Total  
Number of Participants  
[units: participants]
  101     103     204  
Age  
[units: years]
Mean (Standard Deviation)
  63  (10)     62  (11)     63  (11)  
Gender  
[units: participants]
     
Female     48     49     97  
Male     53     54     107  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     5     7  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     2     4  
White     97     96     193  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Time since diagnosis [1]
[units: months]
Mean (Standard Deviation)
  32.6  (46.1)     34.4  (41.4)     33.5  (43.7)  
Neuroendocrine tumour (NET) origin [2]
[units: participants]
     
Pancreas     42     49     91  
Midgut     33     40     73  
Hindgut     11     3     14  
Unknown/Other     15     11     26  
Chromogranin A [3]
[units: participants]
     
≤1 × ULN     33     34     67  
1–2 × ULN     25     18     43  
>2 × ULN     41     48     89  
Unknown     2     3     5  
[1] Time relative to baseline visit (Week 1).
[2] Primary tumour characteristics.
[3] Chromogranin A is an NET marker. ULN: upper limit of normal.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Percentage of Patients Alive & Without Disease Progression   [ Time Frame: Week 48 & 96 ]

3.  Secondary:   Pharmacokinetic Profile of Lanreotide   [ Time Frame: Week 4, 12, 24, 36, 48, 72, 96 ]

4.  Secondary:   Change in the Global Health Status Quality of Life Assessment   [ Time Frame: Week 12 to Week 96 (last visit) ]

5.  Secondary:   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) ]

6.  Secondary:   Percentage of Patients Still Alive Based on Available Overall Survival Data   [ Time Frame: Randomisation to death or last visit, up to 321 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director Endocrinology
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com


Publications of Results:

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00353496     History of Changes
Other Study ID Numbers: 2-55-52030-726
2005-004904-35 ( EudraCT Number )
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