A Study to Assess the Pharmacokinetics (absorption, distribution, metabolisation, excretion), Pharmacodynamics (biochemical and physiological effects of the drug), Efficacy, Safety, Tolerability, and ...

Update Il y a 4 ans
Reference: EUCTR2011-004742-18

A Study to Assess the Pharmacokinetics (absorption, distribution, metabolisation, excretion), Pharmacodynamics (biochemical and physiological effects of the drug), Efficacy, Safety, Tolerability, and Immunogenicity (Immune response) of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma

Woman and Man

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Extract

The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdomyosarcoma.


Inclusion criteria

  • Children with Ewing Family of Tumors or Rhabdomyosarcoma receiving cytotoxic Chemotherapy for malignancy inducing neutropenia