NCT01940601

Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors

An Open Label, Randomized, Active Controlled, Dose Finding Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim at Doses of 300 µg/kg and 670 µg/kg in Pediatric Patients Diagnosed With Solid Tumors Receiving Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Balugrastim	Balugrastim 300 ug/kg and Balugrastim 670 ug/kg
DRUG	Filgrastim	Filgrastim 5 μg/kg

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2013-09-12
• Last updated: 2015-01-14