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Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

Trial Profile

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2019

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At a glance

  • Drugs Anamorelin (Primary)
  • Indications Anorexia; Cachexia
  • Focus Registrational; Therapeutic Use
  • Acronyms ROMANA-1
  • Sponsors Helsinn Therapeutics
  • Most Recent Events

    • 12 Sep 2017 Results (n=829) of pooled post hoc analysis of NCT01387269 and NCT01387282 assessing the baseline characteristics of patients with mGPS 0-2 presented at the 42nd European Society for Medical Oncology Congress
    • 12 Sep 2017 Results (n=829) of pooled post hoc analysis of NCT01387269 and NCT01387282 trials assessing efficacy of anamorelin in cachectic non small cell lung cancer patients with modified Glasgow Prognostic Score 2 (C-reactive protein levels more than 10mg/L and albumin levels less than 3.5g/dL) presented at the 42nd European Society for Medical Oncology Congress
    • 02 Jun 2017 Results of post-hoc pooled analysis (n=829) of two pivotal trials (ROMANA 1 and ROMANA 2) assessing the body weight response with anamorelin, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
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