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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
21
Lipegfilgrastim 100ug/kg
Teva Investigational Site 0103
Plovdiv, Bulgaria
Teva Investigational Site 0101
Sofia, Bulgaria
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
A total of 7 PK samples will be obtained at prespecified periods
Time frame: 16 months
PD:Absolute Neutrophil Count
Time frame: 16 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Teva Investigational Site 0102
Varna, Bulgaria
Teva Investigational Site 0201
Prague, Czechia
Teva Investigational Site 0301
Budapest, Hungary
Teva Investigational Site 0401
Lublin, Poland
Teva Investigational Site 0501
Chelyabinsk, Russia
Teva Investigational Site 0507
Krasnodar, Russia
Teva Investigational Site 0505
Moscow, Russia
Teva Investigational Site 0506
Moscow, Russia
...and 8 more locations