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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


Phase 1
2 Years
17 Years
Open (Enrolling)
Both
Ewing Family of Tumors, Rhabdomyosarcoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

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

Outcome Description:

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

Outcome Time Frame:

16 months

Safety Issue:

No

Principal Investigator

Andreas Lammerich, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merckle GmbH, Teva Ratiopharm

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

XM22-07

NCT ID:

NCT01585649

Start Date:

July 2012

Completion Date:

July 2013

Related Keywords:

  • Ewing Family of Tumors, Rhabdomyosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Ewing's

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