Clinical Trial: Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II, Multicentre, Open Label Study to Evaluate the Efficacy of the Combination of Lanreotide Autogel 120mg and Temozolomide in Patients With Progressive Gastro-entero-pancreatic Neuroendocrine Tu

Brief Summary: The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Disease control rate after 6 months [ Time Frame: 6 months ]

Disease control rate is the total proportion of patients in each category of response i.e. Complete response + partial response + stable disease as measured by the central radiologist using (RECIST, 1.1).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease control rate after 12 months [ Time Frame: 12 months ]
    Disease control rate is the total proportion of patients in each category of response i.e. Complete response + partial response + stable disease as measured by the central radiologist using (RECIST, 1.1). [6 months combination treatment followed by either 6 months Lanreotide Autogel 120 mg maintenance or 6 months wait and see].
  • Time to disease progression or death [ Time Frame: up to 12 months ]
  • Percentage of patients with normalized and stabilized Chromogranin A (CgA) levels after 6 months [ Time Frame: 6 months ]
    Defined as less than 50% increase of CgA level compared to baseline
  • Percentage of patients with normalized and stabilized CgA-levels after 12 months [ Time Frame: 12 months ]
    Defined as less than 50% increase of CgA level compared to baseline
  • Time to partial response within 12 months [ Time Frame: 12 months ]
  • Time to complete response within 12 months [ Time Frame: 12 months ]
  • Duration of partial response within 12 months [ Time Frame: 12 months ]
  • Duration of complete response within 12 months [ Time Frame: 12 months ]
  • Percentage change (greater than or equal to 50%) from baseline in CgA reduction at 12 months [ Time Frame: Baseline, 12 months ]
  • Change from baseline in frequency of symptomatic episodes of diarrhoea after 6 months [ Time Frame: Baseline, 6 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in frequency of symptomatic episodes of flushing after 6 months [ Time Frame: Baseline, 6 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in frequency of symptomatic episodes of diarrhoea after 12 months [ Time Frame: Baseline, 12 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in frequency of symptomatic episodes of flushing after 12 months [ Time Frame: Baseline, 12 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in Quality of Life (QoL) [ Time Frame: Baseline, 6 months ]
    QoL assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) and Quality of Life Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Questionnaires.


Original Secondary Outcome:

  • Disease control rate after 12 months [ Time Frame: 12 months ]
    Disease control rate is the total proportion of patients in each category of response i.e. Complete response + partial response + stable disease as measured by the central radiologist using (RECIST, 1.1). [6 months combination treatment followed by either 6 months Lanreotide ATG 120 mg maintenance or 6 months wait and see].
  • Time to disease progression or death [ Time Frame: up to 12 months ]
  • Percentage of patients with normalized and stabilized Chromogranin A (CgA) levels after 6 months [ Time Frame: 6 months ]
    Defined as less than 50% increase of CgA level compared to baseline
  • Percentage of patients with normalized and stabilized CgA-levels after 12 months [ Time Frame: 12 months ]
    Defined as less than 50% increase of CgA level compared to baseline
  • Time to partial response within 12 months [ Time Frame: 12 months ]
  • Time to complete response within 12 months [ Time Frame: 12 months ]
  • Duration of partial response within 12 months [ Time Frame: 12 months ]
  • Duration of complete response within 12 months [ Time Frame: 12 months ]
  • Percentage change (greater than or equal to 50%) from baseline in CgA reduction at 12 months [ Time Frame: Baseline, 12 months ]
  • Change from baseline in frequency of symptomatic episodes of diarrhoea after 6 months [ Time Frame: Baseline, 6 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in frequency of symptomatic episodes of flushing after 6 months [ Time Frame: Baseline, 6 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in frequency of symptomatic episodes of diarrhoea after 12 months [ Time Frame: Baseline, 12 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in frequency of symptomatic episodes of flushing after 12 months [ Time Frame: Baseline, 12 months ]
    Frequency of the symptomatic episodes assessed by the mean of the last 3 days before the patient visit
  • Change from baseline in Quality of Life (QoL) [ Time Frame: Baseline, 6 months ]
    QoL assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) and Quality of Life Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Questionnaires.


Information By: Ipsen

Dates:
Date Received: September 2, 2014
Date Started: October 2014
Date Completion: June 2017
Last Updated: February 17, 2017
Last Verified: February 2017