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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Merckle GmbH )
ClinicalTrials.gov Identifier:
NCT01585649
First received: April 18, 2012
Last updated: July 29, 2014
Last verified: July 2014

April 18, 2012
July 29, 2014
July 2012
June 2014   (final data collection date for primary outcome measure)
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 [ Time Frame: 16 months ] [ Designated as safety issue: No ]
A total of 7 PK samples will be obtained at prespecified periods
Same as current
Complete list of historical versions of study NCT01585649 on ClinicalTrials.gov Archive Site
PD:Absolute Neutrophil Count [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma
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

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)

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Ewing Family of Tumors, Rhabdomyosarcoma
Drug: Lipegfilgrastim
Lipegfilgrastim 100ug/kg
Experimental: XM22, 100 μg/kg BW
Intervention: Drug: Lipegfilgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female children and adolescents aged 2 to <18 years
  • Written informed consent provided by parent(s)/legal representative(s) of the pediatric patient and patient's assent if appropriate
  • Able to understand and/or follow study instructions alone or with parental assistance
  • Diagnosed with the Ewing family of tumors or Rhabdomyosarcoma
  • Scheduled to receive 1 of the following CTX regimens (inpatient or outpatient)
  • For the Ewing family of tumors:

    • vincristine/ifosfamide/doxorubicin/etoposide (VIDE); with concomitant sodium 2-mercaptoethane sulfonate (MESNA) according to local standards
    • vincristine/doxorubicin/cyclophosphamide alternating with ifosfamide/etoposide (VDC/IE); with concomitant MESNA treatment according to local standards
  • For rhabdomyosarcoma:

    • vincristine/actinomycin/cyclophosphamide (VAC)
    • vincristine/doxorubicin/cyclophosphamide alternating with ifosfamide/etoposide (VDC/IE); with concomitant MESNA treatment according to local standards
  • Chemotherapy-naïve
  • Body weight ≥15 kg
  • White blood cell (WBC) count >2.5 x 109/L, absolute neutrophil count (ANC) ≥1.5 x 109/L, and platelet count ≥100 x 109/L (at screening and prior to CTX)
  • For patients aged ≥12 years, Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (See Appendix A.)
  • 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.
  • Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.

Exclusion Criteria:

  • Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development within 6 months prior to the XM22 administration
  • Known hypersensitivity to filgrastim, pegfilgrastim or lenograstim or any other G-CSF in clinical development
  • History of congenital neutropenia or cyclic neutropenia
  • 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
  • Pregnant or nursing women
  • Fertile patients who do not agree to use highly reliable contraceptive measures during the entire duration of the study
  • Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow (e.g. whole pelvic radiation) for any reason, or any therapeutic radiation within the 3 weeks prior to the XM22 dose
  • Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit
  • Treatment with lithium at screening or planned during the study.
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Czech Republic,   Hungary,   Poland,   Russian Federation,   Ukraine
 
NCT01585649
XM22-07, 2011-004742-18
Not Provided
Teva Pharmaceutical Industries ( Merckle GmbH )
Merckle GmbH
Not Provided
Study Director: Andreas Lammerich, MD Merckle GmbH, Teva Ratiopharm
Teva Pharmaceutical Industries
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP