Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg (CLARINET FORTE)

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: NCT02651987
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE December 11, 2015
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date May 31, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Median Progression Free Survival (PFS) Time [ Time Frame: Every 14 days up to approximately 102 weeks ]
PFS is defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02651987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Median Time to Progression [ Time Frame: Every 14 days up to approximately 102 weeks ]
    Time to Progression is defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression
  • Proportion of subjects alive and without progression [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Proportion of subjects alive and without progression every 12 weeks
  • Overall survival [ Time Frame: Week 48 and at end of the study (up to approximately 102 weeks) ]
    Overall survival defined as the time from first study treatment to death due to any cause
  • Overall Response Rate (ORR) [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    ORR every 12 weeks as per RECIST v1.0. is defined as the proportion of subjects who achieve either Complete response (CR) or Partial response (PR).
  • Disease control rate (DCR) [ Time Frame: Weeks 24, 48 and at end of the study (up to approximately 102 weeks) ]
    The DCR is defined as the rate of CR plus PR plus Stable Disease (SD). DCR evaluated according to RECIST v1.0
  • Best overall response [ Time Frame: At end of the study (up to approximately 102 weeks) ]
    Best overall response according to RECIST v1.0 defined as the best response recorded from the initiation of treatment until disease progression
  • Median duration of Stable Disease (SD) [ Time Frame: Every 14 days up to approximately 102 weeks ]
    Median duration of SD according to RECIST v1.0 defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days until the first occurrence of progressive disease by central assessment
  • Total number of stools and flushing episodes [ Time Frame: During 1 week prior to visit until end of the study (up to approximately 102 weeks) ]
    Symptom control (diarrhoea, flushing) as measured by the total number of stools and flushing episodes during the 7 days prior to the visit reported orally by the subject to the investigator.
  • Change in Quality of life (QLQ-C30) from baseline [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Change in Quality of life from baseline every 12 weeks measured using European Organisation into the Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0.
  • Change in Quality of life (QLQ-GI.NET21) from baseline [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Change in Quality of life from baseline every 12 weeks measured using Quality of Life Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
  • Change in Quality of life (EQ-5D-5L) from baseline [ Time Frame: Every 12 weeks up to approximately 102 weeks ]
    Change in Quality of life from baseline every 12 weeks measured using EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) v1.0 questionnaire.
  • Change in tumour biomarker concentrations from baseline [ Time Frame: Baseline, Weeks 2 and 12 and every 12 weeks thereafter, up to approximately 102 weeks ]
    Concentrations of non-specific (Chromogranin A, neuron specific enolase and 5-hydroxyindoleacetic acid) and specific tumour peptide biomarkers (e.g. pancreatic polypeptide, gastrin, glucagon, and somatostatin)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg
Official Title  ICMJE Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days
Brief Summary This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Tumours
  • Midgut Neuroendocrine Tumours
Intervention  ICMJE Drug: Lanreotide autogel 120 mg
Study Arms  ICMJE Experimental: Lanreotide Autogel®
One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
Intervention: Drug: Lanreotide autogel 120 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 29, 2019)
99
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
100
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ≤20%.
  • Positive somatostatin receptors type 2
  • Progression as assessed by an independent central reviewer according to RECIST v1.0 while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks

Exclusion Criteria:

  • Grade 3 or rapidly progressive (within 12 weeks) NET
  • Any NET other than pancreatic and midgut
  • Previous treatment with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days. Exception made of prior treatment with Octreotide at standard dose stopped for other reason than disease progression.
  • Symptomatic gallbladder lithiasis at screening echography or history of cholelithiasis with no cholecystectomy since then.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Denmark,   France,   Germany,   Ireland,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02651987
Other Study ID Numbers  ICMJE 8-79-52030-326
2014-005607-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date May 2019

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