drugset / Trial / NCT01585649

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

NCT01585649

Phase 1 Completed 21 enrolled Merckle GmbH
NaSingle-groupOpen-labelSupportive care

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)

Timeline

Start
2012-07
Primary completion
2014-06
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject lipegfilgrastim Protein / enzyme biologic 100 ug/kg Subcutaneous

Indications