This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00353496
Recruitment Status : Completed
First Posted : July 18, 2006
Results First Posted : February 18, 2015
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Endocrine Tumors Drug: lanreotide (Autogel formulation) Drug: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Percentage of Patients Alive & Without Disease Progression [ Time Frame: Week 48 & 96 ]
    Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.

  2. Pharmacokinetic Profile of Lanreotide [ Time Frame: Week 4, 12, 24, 36, 48, 72, 96 ]
    Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints

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

  4. 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) ]
  5. Percentage of Patients Still Alive Based on Available Overall Survival Data [ Time Frame: Randomisation to death or last visit, up to 321 weeks ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353496


Locations
Show Show 71 study locations
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Medical Director, Endocrinology Ipsen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00353496    
Other Study ID Numbers: 2-55-52030-726
2005-004904-35 ( EudraCT Number )
First Posted: July 18, 2006    Key Record Dates
Results First Posted: February 18, 2015
Last Update Posted: October 12, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
URL: https://vivli.org/members/ourmembers/
Keywords provided by Ipsen:
Non functioning entero-pancreatic tumours
Additional relevant MeSH terms:
Layout table for MeSH terms
Endocrine Gland Neoplasms
Neoplasms
Neoplasms by Site
 Endocrine System Diseases
Lanreotide
Antineoplastic Agents