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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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)

Detailed Summary:
Sponsor: Merckle GmbH

Current Primary Outcome: PK: Area under the curve, Maximum observed serum concentration (Cmax), Rate constant associated with terminal phase, Mean Residence Time, Time to reach Cmax, and Apparent volume of distribution during terminal phase after non-intravenous administration [ Time Frame: 16 months ]

A total of 7 PK samples will be obtained at prespecified periods


Original Primary Outcome: Same as current

Current Secondary Outcome: PD:Absolute Neutrophil Count [ Time Frame: 16 months ]

Original Secondary Outcome: Same as current

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: April 18, 2012
Date Started: July 2012
Date Completion:
Last Updated: May 17, 2016
Last Verified: May 2016