NCT01585649

PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma

Multicenter, Open-label Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100µg/kg XM22 in 21 Children With Ewing Family of Tumors or Rhabdomyosarcoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Merckle GmbH · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open label study aimed at assessing the pharmacokinetics, pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in children with Ewing family of tumors or rhabdomyosarcoma scheduled to receive chemotherapy (CTX)

Conditions

• Ewing Family of Tumors, Rhabdomyosarcoma

Interventions

Type	Name	Description
DRUG	Lipegfilgrastim	Lipegfilgrastim 100ug/kg

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-06-01
• Completion: 2015-04-01
• First posted: 2012-04-26
• Last updated: 2016-05-18

Locations

18 sites across 6 countries: Bulgaria, Czechia, Hungary, Poland, Russia, Ukraine