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

Ewing Family of Tumors, Rhabdomyosarcoma Clinical Trial

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 Children With Ewing Family of Tumors or Rhabdomyosarcoma

Status Completed

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ewing Family of Tumors, Rhabdomyosarcoma
• Rhabdomyosarcoma
• Sarcoma, Ewing

• NCT number: NCT01585649
• Study type: Interventional
• Source: Teva Pharmaceutical Industries
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Completion date: April 2015