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

Primary Purpose

Ewing Family of Tumors, Rhabdomyosarcoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lipegfilgrastim
Sponsored by
Merckle GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ewing Family of Tumors, Rhabdomyosarcoma

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teva Investigational Site 0103
  • Teva Investigational Site 0101
  • Teva Investigational Site 0102
  • Teva Investigational Site 0201
  • Teva Investigational Site 0301
  • Teva Investigational Site 0401
  • Teva Investigational Site 0501
  • Teva Investigational Site 0504
  • Teva Investigational Site 0507
  • Teva Investigational Site 0505
  • Teva Investigational Site 0506
  • Teva Investigational Site 0508
  • Teva Investigational Site 0502
  • Teva Investigational Site 0701
  • Teva Investigational Site 0705
  • Teva Investigational Site 0702
  • Teva Investigational Site 0704
  • Teva Investigational Site 0703

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XM22, 100 μg/kg BW

Arm Description

Outcomes

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

Secondary Outcome Measures

PD:Absolute Neutrophil Count

Full Information

First Posted
April 18, 2012
Last Updated
May 17, 2016
Sponsor
Merckle GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01585649
Brief Title
PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merckle GmbH

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ewing Family of Tumors, Rhabdomyosarcoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XM22, 100 μg/kg BW
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lipegfilgrastim
Intervention Description
Lipegfilgrastim 100ug/kg
Primary Outcome Measure Information:
Title
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
Description
A total of 7 PK samples will be obtained at prespecified periods
Time Frame
16 months
Secondary Outcome Measure Information:
Title
PD:Absolute Neutrophil Count
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Lammerich, MD
Organizational Affiliation
Merckle GmbH, Teva Ratiopharm
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 0103
City
Plovdiv
Country
Bulgaria
Facility Name
Teva Investigational Site 0101
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 0102
City
Varna
Country
Bulgaria
Facility Name
Teva Investigational Site 0201
City
Praha 5
Country
Czech Republic
Facility Name
Teva Investigational Site 0301
City
Budapest
Country
Hungary
Facility Name
Teva Investigational Site 0401
City
Lublin
Country
Poland
Facility Name
Teva Investigational Site 0501
City
Chelyabinsk
Country
Russian Federation
Facility Name
Teva Investigational Site 0504
City
Ekaterinburg
Country
Russian Federation
Facility Name
Teva Investigational Site 0507
City
Krasnodar
Country
Russian Federation
Facility Name
Teva Investigational Site 0505
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 0506
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 0508
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 0502
City
St. Petersburg
Country
Russian Federation
Facility Name
Teva Investigational Site 0701
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Teva Investigational Site 0705
City
Donetsk
Country
Ukraine
Facility Name
Teva Investigational Site 0702
City
Kharkiv
Country
Ukraine
Facility Name
Teva Investigational Site 0704
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 0703
City
Lviv
Country
Ukraine

12. IPD Sharing Statement

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

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