Children with Ewing Family of Tumors or Rhabdomyosarcoma receiving cytotoxic Chemotherapy for malignancy inducing neutropenia
Conditions
Interventions
Product Code: XM22
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lipegfilgrastim
CAS Number: 1117844-87-7
Current Sponsor code: XM22
Other descriptive name: glyco-PEGylated r-metHuG
Sponsors
Merckle GmbH, a member of the ratiopharm group, a subsidiary of Teva Pharmaceutical Industries Ltd. Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female children and adolescents aged 2 to 2.5 x 10(9)/L, absolute neutrophil count (ANC) =1.5 x 10(9)/L, and platelet count =100 x 10(9)/L (at screening and prior to CTX). 9. For patients aged =12 years, Eastern Cooperative Oncology Group (ECOG) performance status =2 10. Fertile patients (male or female) must use highly reliable contraceptive measures (i.e. two of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence). For purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation. 11. Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit. Are the trial subjects under 18? yes Number of subjects for this age range: 21 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development within 6 months prior to the XM22 administration 2. Known hypersensitivity to filgrastim, pegfilgrastim or lenograstim or any other G-CSF in clinical development 3. History of congenital neutropenia or cyclic neutropenia 4. Any illness or condition that in the opinion of the Investigator may affect the safety of the patient or the evaluation of any study endpoint 5. Pregnant or nursing women 6. Fertile patients who do not agree to use highly reliable contraceptive measures during the entire duration of the study 7. Prior bone marrow or stem cell transplant, or prior radiation to = 25% of bone marrow (eg, whole pelvic radiation) for any reason, or any therapeutic radiation within the 3 weeks prior to the XM22 dose 8. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit 9. Treatment with lithium at screening or planned during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objectives are to assess the pharmacodynamics (PD), efficacy, safety, tolerability, and immunogenicity of this single dose in the same patient population.;Primary end point(s): Assessment of pharmacokinetics of single dose XM22;Timepoint(s) of evaluation of this end point: Pharmacokinetic profile up to 240 hours postdose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamic (ANC, CD34+), Efficacy, Safety, Tolerability, Immunogenicity;Timepoint(s) of evaluation of this end point: Pharmacodynamic (ANC, CD34+) until day 15 Efficacy, Safety, Tolerability until day 21 Immunogenicity until day 21 and follow-up on day 180 and day 360 | — |
Countries
Bulgaria, Hungary, Poland, Russian Federation, Serbia, Ukraine
Contacts
Public ContactDr med Andreas Lammerich
Merckle GmbH
Outcome results
None listed