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Trial record 6 of 9 for:    Clarinet

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

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ClinicalTrials.gov Identifier: NCT02651987
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Pancreatic Tumours Midgut Neuroendocrine Tumours Drug: Lanreotide autogel 120 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: Lanreotide Autogel®
One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.
Drug: Lanreotide autogel 120 mg



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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).

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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)

  11. 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.

  12. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02651987


Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 32 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Medical Director Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02651987     History of Changes
Other Study ID Numbers: 8-79-52030-326
2014-005607-24 ( EudraCT Number )
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Pancreatic Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs