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

NCT01585649 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-05-18

No results posted yet for this study

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

DRUG

Lipegfilgrastim

Lipegfilgrastim 100ug/kg

Sponsors & Collaborators

  • Merckle GmbH

    lead INDUSTRY

Principal Investigators

  • Andreas Lammerich, MD · Merckle GmbH, Teva Ratiopharm

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-06-30
Completion
2015-04-30

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585649 on ClinicalTrials.gov