A randomised, double-blind, single-dose study to compare pharmacokinetic characteristics and safety of FKB238 with those of Avastin in healthy male subjects (HMR code 14-009)

Trial Profile

A randomised, double-blind, single-dose study to compare pharmacokinetic characteristics and safety of FKB238 with those of Avastin in healthy male subjects (HMR code 14-009)

Completed
Phase of Trial: Phase I

Latest Information Update: 07 Jun 2017

At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Non-small cell lung cancer; Solid tumours
  • Focus First in man; Pharmacokinetics
  • Sponsors Fujifilm Kyowa Kirin Biologics
  • Most Recent Events

    • 02 Jun 2017 Status changed from recruiting to completed, according to results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 02 Jun 2017 Primary endpoint (Pharmacokinetic parameter: AUC0-t) has been met, according to results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 02 Jun 2017 Primary endpoint (Pharmacokinetic parameter: AUC0-inf) has been met, according to results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
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