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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Ewing Family of Tumors, Rhabdomyosarcoma	Drug: Lipegfilgrastim	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	21 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	July 2012
Actual Primary Completion Date :	June 2014
Actual Study Completion Date :	April 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: XM22, 100 μg/kg BW	Drug: Lipegfilgrastim; Lipegfilgrastim 100ug/kg

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
   A total of 7 PK samples will be obtained at prespecified periods

Secondary Outcome Measures :

1. PD:Absolute Neutrophil Count [ Time Frame: 16 months ]

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Merckle GmbH
ClinicalTrials.gov Identifier:	NCT01585649 History of Changes
Other Study ID Numbers:	XM22-07; 2011-004742-18 ( EudraCT Number )
First Posted:	April 26, 2012
Last Update Posted:	May 18, 2016
Last Verified:	May 2016

Additional relevant MeSH terms:

Rhabdomyosarcoma; Sarcoma, Ewing; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type	Neoplasms; Sarcoma; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue