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A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

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ClinicalTrials.gov Identifier: NCT02190721
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

July 11, 2014
July 15, 2014
April 9, 2018
May 12, 2015
April 4, 2017   (Final data collection date for primary outcome measure)
Percentage of participants with Adverse Events [ Time Frame: 90 Days ]
Safety will be assessed by evaluating adverse event reports throughout the study using descriptive statistics
  • Percentage of participants with Adverse Events [ Time Frame: 90 Days ]
    Safety will be assessed by evaluating adverse event reports throughout the study using descriptive statistics
  • Incidence of febrile neutropenia. [ Time Frame: 15 Days ]
    During cycle 1: The first dose of tbo-filgrastim will be administered after 24 hours (±3 hours) following the end of myelosuppressive chemotherapy (CTX) in week 1 of the study cycle 1.
Complete list of historical versions of study NCT02190721 on ClinicalTrials.gov Archive Site
  • Change from Baseline in blood lab results [ Time Frame: Day 1 and 21 ]
    clinical laboratory test results at screening and at the end-of-study visit
  • Change from Baseline in Vital Signs [ Time Frame: 21 Days ]
    vital sign measurements at screening, throughout the study treatment, and at the end-of-study visit
  • Electrocardiography (ECG) findings [ Time Frame: Day 1, 4 & 6 hours post dose, Day 21 ]
  • Concomitant medication usage [ Time Frame: 90 Days ]
    Any concomitant medication usage throughout the study
  • Spleen sonography [ Time Frame: Day 1, 4, and 21 ]
  • Local tolerability at the injection site [ Time Frame: 1 hour (±30 minutes) after each study drug injection ]
    Using Local Tolerability Assessment Scale ranging from Pain severity 0 (Absent) to 3 (Spontaneously painful)
  • Anti-drug antibody assessment [ Time Frame: Day 1, 21, and 90 ]
  • Overall Survival [ Time Frame: 90 Days ]
  • Maximum observed plasma/serum drug concentration (Cmax) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • Time to maximum observed drug concentration (tmax) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • area under the serum drug concentration (AUC0-12) [ Time Frame: 12 hours ]
    area under the serum drug concentration by time curve from time 0 to 12 hours postdose (AUC0-12) Up to 12 Hours from Filgrastim administration
  • Area under the serum concentration (AUC0-∞) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • Elimination half-life (t½) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • Incidence of severe neutropenia (DSN, ANC <0.5 × 109/L) [ Time Frame: Day 15 ]
    During Cycle 1
  • Area under the curve of absolute neutrophil count (AUCANC) [ Time Frame: Day 15 ]
    During Cycle 1
  • ANC nadir (measured in 109/L) [ Time Frame: Day 15 ]
    During Cycle 1
  • Time to ANC nadir [ Time Frame: Day 15 ]
    During Cycle 1
  • Time to ANC recovery to ≥1.0 × 109/L [ Time Frame: Day 15 ]
    During Cycle 1
  • Time to ANC recovery to ≥2.0 × 109/ [ Time Frame: Day 15 ]
    During Cycle 1
  • Incidence of febrile neutropenia [ Time Frame: 15 Days ]
    During cycle 1: The first dose of tbo-filgrastim will be administered after 24 hours (±3 hours) following the end of myelosuppressive chemotherapy (CTX) in week 1 of the study cycle 1.
  • Duration of severe neutropenia (DSN, ANC <0.5 × 109/L) [ Time Frame: Day 15 ]
    During Cycle 1
  • Change from Baseline in blood lab results [ Time Frame: Day 1 and 21 ]
    clinical laboratory test results at screening and at the end-of-study visit
  • Change from Baseline in Vital Signs [ Time Frame: 21 Days ]
    vital sign measurements at screening, throughout the study treatment, and at the end-of-study visit
  • Electrocardiography (ECG) findings [ Time Frame: Day 1, 4 & 6 hours post dose, Day 21 ]
  • Concomitant medication usage [ Time Frame: 90 Days ]
    Any concomitant medication usage throughout the study
  • Spleen sonography [ Time Frame: Day 1, 4, and 21 ]
  • Local tolerability at the injection site [ Time Frame: 1 hour (±30 minutes) after each study drug injection ]
  • Anti-drug antibody assessment [ Time Frame: Day 1, 21, and 90 ]
  • Overall Survival [ Time Frame: 90 Days ]
  • Maximum observed plasma/serum drug concentration (Cmax) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • Time to maximum observed drug concentration (tmax) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • area under the serum drug concentration (AUC0-12) [ Time Frame: 12 hours ]
    area under the serum drug concentration by time curve from time 0 to 12 hours postdose (AUC0-12) Up to 12 Hours from Filgrastim administration
  • Area under the serum concentration (AUC0-∞) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • Elimination half-life (t½) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration
  • Incidence and duration of severe neutropenia (DSN, ANC <0.5 × 109/L) [ Time Frame: Day 15 ]
    During Cycle 1
  • Area under the curve of absolute neutrophil count (AUCANC) [ Time Frame: Day 15 ]
    During Cycle 1
  • ANC nadir (measured in 109/L) [ Time Frame: Day 15 ]
    During Cycle 1
  • Time to ANC nadir [ Time Frame: Day 15 ]
    During Cycle 1
  • Time to ANC recovery to ≥1.0 × 109/L [ Time Frame: Day 15 ]
    During Cycle 1
  • Time to ANC recovery to ≥2.0 × 109/ [ Time Frame: Day 15 ]
    During Cycle 1
Not Provided
Not Provided
 
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 ?g/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents with solid tumors without bone marrow involvement.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neutropenia
Drug: tbo-filgrastim
5 μg/kg
Experimental: tbo-filgrastim
Patients will receive subcutaneous doses of tbo-filgrastim 5 μg/kg body weight daily; each daily dose, to be administered at the investigative site
Intervention: Drug: tbo-filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
April 4, 2017
April 4, 2017   (Final data collection date for primary outcome measure)

Inclusion:

  1. Male or female infants, children and adolescents aged 1 month to <16 years.
  2. Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
  3. Body weight ≥5 kg.
  4. Patients must have an initial diagnosis and histologic proof of their malignancy. All enrolled subjects should have signed consent for a CTX regimen that is known to be myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of 0.5 × 109/L for at least 3 days. These regimens would include at least one of the following:

    • Etoposide
    • doxorubicin
    • ifosfamide
    • cyclophosphamide
  5. ANC and platelet count: Patients must have an ANC >1 × 109/L and a platelet count >100 × 109/L to be eligible for therapy at the start of CTX.
  6. Normal cardiac, renal, and hepatic function.
  7. All subjects must have a life expectancy of 12 weeks or more.
  8. Performance Status: Lansky performance score >60 (age 1 to <16 years).

    • More criteria may apply, please contact the investigator for more information.

Exclusion:

  1. Bone marrow involvement.
  2. Active myelogenous leukemia or history of myelogenous leukemia.
  3. Previous treatment with colony-stimulating factors (granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, interleukin 11 [IL-11]) less than 6 weeks prior to study entry.
  4. History of congenital neutropenia or cyclic neutropenia.
  5. Pregnant or nursing female patients.
  6. Fertile patients who do not agree to use highly reliable contraceptive measures Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow within the 4 weeks prior to the first tbo-filgrastim dose.
  7. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
  8. Treatment with lithium at screening or planned during the study

    • More criteria may apply, please contact the investigator for more information.
Sexes Eligible for Study: All
1 Month to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Croatia,   Hungary,   Poland,   Romania,   Russian Federation,   Ukraine,   United States
Serbia
 
NCT02190721
XM02-ONC-201
2014-001772-55 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Teva Pharmaceutical Industries, Ltd.
Not Provided
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
Teva Pharmaceutical Industries
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP