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

NCT ID: NCT01585649

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-04-30

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)

Conditions

Ewing Family of Tumors, Rhabdomyosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

XM22, 100 μg/kg BW

Group Type: EXPERIMENTAL

Lipegfilgrastim

Intervention Type: DRUG

Lipegfilgrastim 100ug/kg

Interventions

Lipegfilgrastim

Lipegfilgrastim 100ug/kg

Intervention Type: DRUG

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merckle GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Lammerich, MD

Role: STUDY_DIRECTOR

Merckle GmbH, Teva Ratiopharm

Locations

Teva Investigational Site 0103

Plovdiv, , Bulgaria

Teva Investigational Site 0101

Sofia, , Bulgaria

Teva Investigational Site 0102

Varna, , Bulgaria

Teva Investigational Site 0201

Prague, , Czechia

Teva Investigational Site 0301

Budapest, , Hungary

Teva Investigational Site 0401

Lublin, , Poland

Teva Investigational Site 0501

Chelyabinsk, , Russia

Teva Investigational Site 0507

Krasnodar, , Russia

Teva Investigational Site 0505

Moscow, , Russia

Teva Investigational Site 0506

Moscow, , Russia

Teva Investigational Site 0508

Moscow, , Russia

Teva Investigational Site 0502

Saint Petersburg, , Russia

Teva Investigational Site 0504

Yekaterinburg, , Russia

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

Countries

Bulgaria; Czechia; Hungary; Poland; Russia; Ukraine

Other Identifiers

2011-004742-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

XM22-07

Identifier Type: -

Identifier Source: org_study_id