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Withdrawn prior to enrolment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
- 13 Jan 2015 Status changed from not yet recruiting to withdrawn prior to enrolment as reported by ClinicalTrials.gov record.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.