An open label, randomized, active controlled, dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim at doses of 300 mcg/kg and 670 mcg/kg in pediatric patients diagnosed with solid tumors receiving chemotherapy.

Trial Profile

An open label, randomized, active controlled, dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim at doses of 300 mcg/kg and 670 mcg/kg in pediatric patients diagnosed with solid tumors receiving chemotherapy.

Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Balugrastim (Primary) ; Filgrastim
  • Indications Solid tumours
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Teva Pharmaceutical Industries
  • Most Recent Events

    • 13 Jan 2015 Status changed from not yet recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov record.
    • 26 Feb 2014 Planned End Date changed from 1 Oct 2015 to 1 Dec 2015 as reported by ClinicalTrials.gov record.
    • 28 Jan 2014 Planned End Date changed from 1 Apr 2015 to 1 Oct 2015 as reported by ClinicalTrials.gov record.
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