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  • ANAM-17-21

    Acronym: 

    ANAM-17-21

    ACTRN/NCT /ethics: 

    NCT03743064

    Scientific title: 

    A phase III, randomised, double-blind, placebo-controlled, mutli-centre study to evaluate the efficacy and safety of anamorelin HCL for the treatment of malignancy associated weight loss and anorexia in adult patients with advanced NSCLC.

    Summary of trial and patient characteristics

    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase Phase III Tumour Stream NSCLC with weight loss
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date
    Molecular Target Anticipated End Date
    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream NSCLC with weight loss
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date
    Anticipated End Date

    Trial Summary

    Multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 316 patients with advanced NSCLC with cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 24 weeks. Patients will be instructed to take the study drug at least 1 hour before their first meal of the day

    Lay Summary

    A phase III, randomised, double-blind, placebo-controlled, mutli-centre study to evaluate the efficacy and safety of anamorelin HCL for the treatment of malignancy associated weight loss and anorexia in adult patients with advanced NSCLC.

    Sponsor / Cooperative group

    Helsinn Healthcare SA

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Calvary Central Districts Hospital Julie Rowe julie.rowe@calvarycare.org.au 08 8239 9536 Dr Vineet Kwatra Not Yet Recruiting