Multiple, fixed-dose, comparative efficacy and safety evaluation of RGB-02 and Neulasta® in patients undergoing chemotherapy treatment known to induce neutropenia.

Trial Profile

Multiple, fixed-dose, comparative efficacy and safety evaluation of RGB-02 and Neulasta® in patients undergoing chemotherapy treatment known to induce neutropenia.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Registrational; Therapeutic Use
  • Sponsors Gedeon Richter
  • Most Recent Events

    • 12 Sep 2017 Primary endpoint has not been met. (Duration of severe neutropenia (ANC 0.5 x10^9/L) in Cycle 1) as per results presented at the 42nd European Society for Medical Oncology Congress
    • 12 Sep 2017 Results presented at the 42nd European Society for Medical Oncology Congress
    • 20 May 2015 New trial record
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