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
  Purpose

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)


Condition Intervention Phase
Ewing Family of Tumors, Rhabdomyosarcoma
Drug: Lipegfilgrastim
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • PD:Absolute Neutrophil Count [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XM22, 100 μg/kg BW Drug: Lipegfilgrastim
Lipegfilgrastim 100ug/kg

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585649

Locations
Bulgaria
Teva Investigational Site 0103
Plovdiv, Bulgaria
Teva Investigational Site 0101
Sofia, Bulgaria
Teva Investigational Site 0102
Varna, Bulgaria
Czech Republic
Teva Investigational Site 0201
Praha 5, Czech Republic
Hungary
Teva Investigational Site 0301
Budapest, Hungary
Poland
Teva Investigational Site 0401
Lublin, Poland
Russian Federation
Teva Investigational Site 0501
Chelyabinsk, Russian Federation
Teva Investigational Site 0504
Ekaterinburg, Russian Federation
Teva Investigational Site 0507
Krasnodar, Russian Federation
Teva Investigational Site 0505
Moscow, Russian Federation
Teva Investigational Site 0506
Moscow, Russian Federation
Teva Investigational Site 0508
Moscow, Russian Federation
Teva Investigational Site 0502
St. Petersburg, Russian Federation
Ukraine
Teva Investigational Site 0701
Dnipropetrovsk, Ukraine
Teva Investigational Site 0705
Donetsk, Ukraine
Teva Investigational Site 0702
Kharkiv, Ukraine
Teva Investigational Site 0704
Kyiv, Ukraine
Teva Investigational Site 0703
Lviv, Ukraine
Sponsors and Collaborators
Merckle GmbH
Investigators
Study Director: Andreas Lammerich, MD Merckle GmbH, Teva Ratiopharm
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Merckle GmbH )
ClinicalTrials.gov Identifier: NCT01585649     History of Changes
Other Study ID Numbers: XM22-07, 2011-004742-18
Study First Received: April 18, 2012
Last Updated: July 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Serbia: Ethics Committee
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee

Additional relevant MeSH terms:
Rhabdomyosarcoma
Sarcoma, Ewing
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Osteosarcoma
Sarcoma

ClinicalTrials.gov processed this record on October 29, 2014