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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

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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

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 02 Nov 2021

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At a glance

  • Drugs Balugrastim (Primary) ; Filgrastim
  • Indications Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Teva Branded Pharmaceutical Products R&D; 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    • 13 Jan 2015 Status changed from not yet recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov record.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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