Back to resultsA Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Primary Purpose
Neutropenia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tbo-filgrastim
Sponsored by
About this trial
This is an interventional treatment trial for Neutropenia focused on measuring Neutropenia
Eligibility Criteria
Inclusion:
- Male or female infants, children and adolescents aged 1 month to <16 years.
- Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
- Body weight ≥5 kg.
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
- 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.
- Normal cardiac, renal, and hepatic function.
- All subjects must have a life expectancy of 12 weeks or more.
Performance Status: Lansky performance score >60 (age 1 to <16 years).
- More criteria may apply, please contact the investigator for more information.
Exclusion:
- Bone marrow involvement.
- Active myelogenous leukemia or history of myelogenous leukemia.
- 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.
- History of congenital neutropenia or cyclic neutropenia.
- Pregnant or nursing female patients.
- 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.
- 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
- More criteria may apply, please contact the investigator for more information.
Sites / Locations
- Teva Investigational Site 12958
- Teva Investigational Site 12951
- Teva Investigational Site 12954
- Teva Investigational Site 12953
- Teva Investigational Site 12959
- Teva Investigational Site 12960
- Teva Investigational Site 12957
- Teva Investigational Site 59104
- Teva Investigational Site 59105
- Teva Investigational Site 60015
- Teva Investigational Site 60014
- Teva Investigational Site 60016
- Teva Investigational Site 51186
- Teva Investigational Site 51185
- Teva Investigational Site 51184
- Teva Investigational Site 53249
- Teva Investigational Site 53248
- Teva Investigational Site 53245
- Teva Investigational Site 53246
- Teva Investigational Site 53247
- Teva Investigational Site 52063
- Teva Investigational Site 52064
- Teva Investigational Site 52065
- Teva Investigational Site 50282
- Teva Investigational Site 50281
- Teva Investigational Site 50284
- Teva Investigational Site 50280
- Teva Investigational Site 50283
- Teva Investigational Site 58147
- Teva Investigational Site 58145
- Teva Investigational Site 58148
- Teva Investigational Site 58146
- Teva Investigational Site 58149
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tbo-filgrastim
Arm Description
Patients will receive subcutaneous doses of tbo-filgrastim 5 μg/kg body weight daily; each daily dose, to be administered at the investigative site
Outcomes
Primary Outcome Measures
Participants With Adverse Events (AEs)
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. A treatment-emergent AE (TEAE) is an AE occurring during the timeframe. A non-TEAE is any AE not considered a TEAE.
Severity was rated by the investigator using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale where 3=severe but not life-threatening, 4=life-threatening and 5=death. Relation of AE to treatment was determined by the investigator (related=reasonable possibility). Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results
Serum chemistry tests included alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, indirect bilirubin, total bilirubin, calcium, creatinine, gammaglutamyl transpeptidase (GGT), glucose, potassium, lactate dehydrogenase (LDH), phosphate, sodium and uric acid.
Only tests with potentially clinically significant abnormal results are reported.
ULN = upper limit of normal
Participants With Potentially Clinically Significant Abnormal Hematology Results
Hematology tests included Basophils ABS (x 10^9/L), Basophils (%), Eosinophils ABS (x 10^9/L), Eosinophils (%), Hematocrit (%), Hemoglobin (g/L), Lymphocytes Absolute Count (ABS) (x 10^9/L), Lymphocytes (%), Monocytes ABS (x 10^9/L), Monocytes (%), Neutrophils ABS (x 10^9/L), Neutrophils (%), Platelets (x 10^9/L), Red Blood Cell (RBC) (x 10^12/L), White Blood Cell (WBC) (x 10^9/L).
Only tests with potentially clinically significant abnormal results are reported.
ULN = upper limit of normal
Participants With Potentially Clinically Significant Abnormal Vital Signs
Vital sign tests included Pulse Rate (bpm), Systolic BP (mmHg), Diastolic BP (mmHg), Respiratory Rate (bpm), and Temperature (°C).
Only tests with potentially clinically significant abnormal results are reported.
Participants With Potentially Clinically Significant Abnormal Electrocardiogram Results
Triplicate 12-lead ECGs were conducted at screening, predose, 4 and 6 hours postdose on day 1 of tbo-filgrastim administration, and at the end-of-study visit. The ECGs were interpreted by both the investigator and a qualified physician at the central diagnostic center as normal, abnormal not clinically significant, or abnormal clinically significant. The following parameters were measured/derived for each ECG assessment: heart rate, PR interval, RR interval, QT interval, corrected QT interval according to Fridericia's formula (QTcF), corrected QT interval according to Bazett's formula (QTcB), QRS duration, and QRS axis.
The count of participants with potentially clinically significant ECG findings is reported.
Participants With Negative Shifts From Baseline to End of Study in Physical Exam Findings
Physical examination was performed at screening and at the end-of-study visit. The following body systems were marked as normal or abnormal and if abnormal, whether clinically significant: Head, ears, eyes, nose and throat (HEENT), chest and lungs, heart, abdomen, skin, lymph nodes and neurological.
Any physical examination finding that is judged by the investigator as a clinically significant change (worsening) compared with a baseline value were considered as an adverse event.
Counts of participants with a negative shift from baseline in any of the body systems (including shifts from normal to abnormal, not clinically significant) are presented.
Participants With Injection Site Reactions to Tbo-Filgrastim Administration
Using Local Tolerability Assessment Scale ranging from Pain severity 0 (Absent) to 3 (Spontaneously painful)
Participants With Negative Shifts From Baseline to End of Study in Spleen Sonography Findings
The investigator assessed spleen sonography findings as normal, abnormal not clinically significant, or abnormal clinically significant.
Data representing counts of participants with a negative shift from baseline in spleen sonography findings (including shifts from normal to abnormal, not clinically significant) are presented.
Participants Who Were Alive at the 90 Day Follow-Up
Summary of participant survival at 90 day follow-up.
Secondary Outcome Measures
Participants With Positive Immunogenicity Findings Tested at Four Study Timepoints
Blood was drawn for the assessment of anti-drug antibody (ADA) at screening, at the end-of-study visit, and at 30 and 90 days after the last administration of tbo-filgrastim in chemotherapy (CTX) cycle 1.
The main endpoint from the assessment was the presence of antibodies in the sample, reported as positive or negative. Participants with positive results are summarized.
Maximum Observed Serum Concentration (Cmax) of Tbo-Filgrastim
Time to Maximum Observed Serum Concentration (Tmax) of Tbo-Filgrastim
Area Under The Serum Concentration-Time Curve From Time 0 To Time Of Last Quantifiable Concentration (AUClast)
Area Under The Serum Concentration-Time Curve From Time 0 To 12 Hours Postdose (AUC0-12)
AUC From Time 0 to Infinity (AUC0-inf)
Elimination Half-life (t1/2)
Apparent Clearance (CL/F)
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Percentage of the AUC0-∞ That Is Due To the Extrapolation (%AUCext)
Terminal Elimination Rate (Lambda-z)
Participants With Severe Neutropenia
Count of participants who had an incidence of severe neutropenia, defined as any value of absolute neutrophil count (ANC) <0.5 * 10^9/L at any time.
Duration of Severe Neutropenia
The duration of severe neutropenia was derived by counting the number of days with absolute neutrophil count (ANC) values <0.5 * 10^9/L.
Area Under The Serum Drug Concentration By Time Curve Of Absolute Neutrophil Count (AUC ANC)
Absolute Neutrophil Count (ANC) Nadir
ANC nadir (measured in 10^9/L) is the lowest ANC recorded.
Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Tbo-filgrastim Administration
Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Chemotherapy
Time to ANC Recovery To ≥1.0 * 10^9/L From ANC Nadir
Time to ANC Recovery To ≥2.0 * 10^9/L From ANC Nadir
Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Tbo-filgrastim Administration
Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Tbo-filgrastim Administration
Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Chemotherapy
Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Chemotherapy
Participants With Febrile Neutropenia During the First Cycle of Chemotherapy
Febrile neutropenia was defined as an axillary or external ear temperature >38.3°C (100.94°F) or 2 consecutive readings >37.8°C (100.04°F) at least 2 hours apart and an ANC <0.5 * 10^9/L. The efficacy variable was evaluated for up to 21 days from the start of the first cycle of chemotherapy.
Full Information
NCT ID
NCT02190721
First Posted
July 11, 2014
Last Updated
December 8, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02190721
Brief Title
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
April 4, 2017 (Actual)
Study Completion Date
April 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
Keywords
Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tbo-filgrastim
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
tbo-filgrastim
Intervention Description
5 μg/kg
Primary Outcome Measure Information:
Title
Participants With Adverse Events (AEs)
Description
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. A treatment-emergent AE (TEAE) is an AE occurring during the timeframe. A non-TEAE is any AE not considered a TEAE.
Severity was rated by the investigator using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale where 3=severe but not life-threatening, 4=life-threatening and 5=death. Relation of AE to treatment was determined by the investigator (related=reasonable possibility). Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame
Non-TEAE: signing of informed consent to Day -1 (last day of CTX in week 1). And > 30 days after last dose of tbo-filgrastim (Day 46+). TEAE timeframe: Day 1 (start of tbo-filgrastim) to <= 30 days after the last dose (up to Day 45)
Title
Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results
Description
Serum chemistry tests included alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, indirect bilirubin, total bilirubin, calcium, creatinine, gammaglutamyl transpeptidase (GGT), glucose, potassium, lactate dehydrogenase (LDH), phosphate, sodium and uric acid.
Only tests with potentially clinically significant abnormal results are reported.
ULN = upper limit of normal
Time Frame
Day 1 (start of tbo-filgrastim administration) up to Day 21
Title
Participants With Potentially Clinically Significant Abnormal Hematology Results
Description
Hematology tests included Basophils ABS (x 10^9/L), Basophils (%), Eosinophils ABS (x 10^9/L), Eosinophils (%), Hematocrit (%), Hemoglobin (g/L), Lymphocytes Absolute Count (ABS) (x 10^9/L), Lymphocytes (%), Monocytes ABS (x 10^9/L), Monocytes (%), Neutrophils ABS (x 10^9/L), Neutrophils (%), Platelets (x 10^9/L), Red Blood Cell (RBC) (x 10^12/L), White Blood Cell (WBC) (x 10^9/L).
Only tests with potentially clinically significant abnormal results are reported.
ULN = upper limit of normal
Time Frame
Day 1 (start of tbo-filgrastim administration) up to Day 21
Title
Participants With Potentially Clinically Significant Abnormal Vital Signs
Description
Vital sign tests included Pulse Rate (bpm), Systolic BP (mmHg), Diastolic BP (mmHg), Respiratory Rate (bpm), and Temperature (°C).
Only tests with potentially clinically significant abnormal results are reported.
Time Frame
Day 1 (start of tbo-filgrastim administration) up to Day 21
Title
Participants With Potentially Clinically Significant Abnormal Electrocardiogram Results
Description
Triplicate 12-lead ECGs were conducted at screening, predose, 4 and 6 hours postdose on day 1 of tbo-filgrastim administration, and at the end-of-study visit. The ECGs were interpreted by both the investigator and a qualified physician at the central diagnostic center as normal, abnormal not clinically significant, or abnormal clinically significant. The following parameters were measured/derived for each ECG assessment: heart rate, PR interval, RR interval, QT interval, corrected QT interval according to Fridericia's formula (QTcF), corrected QT interval according to Bazett's formula (QTcB), QRS duration, and QRS axis.
The count of participants with potentially clinically significant ECG findings is reported.
Time Frame
Day 1 (start of tbo-filgrastim administration) pre-dose, 4 hours post dose and 6 hours post dose; Day 21 (end of study visit)
Title
Participants With Negative Shifts From Baseline to End of Study in Physical Exam Findings
Description
Physical examination was performed at screening and at the end-of-study visit. The following body systems were marked as normal or abnormal and if abnormal, whether clinically significant: Head, ears, eyes, nose and throat (HEENT), chest and lungs, heart, abdomen, skin, lymph nodes and neurological.
Any physical examination finding that is judged by the investigator as a clinically significant change (worsening) compared with a baseline value were considered as an adverse event.
Counts of participants with a negative shift from baseline in any of the body systems (including shifts from normal to abnormal, not clinically significant) are presented.
Time Frame
Baseline: Day -21, Day 21 (end of study visit)
Title
Participants With Injection Site Reactions to Tbo-Filgrastim Administration
Description
Using Local Tolerability Assessment Scale ranging from Pain severity 0 (Absent) to 3 (Spontaneously painful)
Time Frame
Day 1 (start of tbo-filgrastim administration) up to Day 14
Title
Participants With Negative Shifts From Baseline to End of Study in Spleen Sonography Findings
Description
The investigator assessed spleen sonography findings as normal, abnormal not clinically significant, or abnormal clinically significant.
Data representing counts of participants with a negative shift from baseline in spleen sonography findings (including shifts from normal to abnormal, not clinically significant) are presented.
Time Frame
Baseline: Day -21, Day 21 (end of study visit)
Title
Participants Who Were Alive at the 90 Day Follow-Up
Description
Summary of participant survival at 90 day follow-up.
Time Frame
90 days post end of study visit (111 days from start of tbo-filgrastim administration)
Secondary Outcome Measure Information:
Title
Participants With Positive Immunogenicity Findings Tested at Four Study Timepoints
Description
Blood was drawn for the assessment of anti-drug antibody (ADA) at screening, at the end-of-study visit, and at 30 and 90 days after the last administration of tbo-filgrastim in chemotherapy (CTX) cycle 1.
The main endpoint from the assessment was the presence of antibodies in the sample, reported as positive or negative. Participants with positive results are summarized.
Time Frame
Baseline (Day -21), Day 21 (end of study visit), Day 51 (30 Day follow-up) and Day 111 (90 Day follow-up)
Title
Maximum Observed Serum Concentration (Cmax) of Tbo-Filgrastim
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Time to Maximum Observed Serum Concentration (Tmax) of Tbo-Filgrastim
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Area Under The Serum Concentration-Time Curve From Time 0 To Time Of Last Quantifiable Concentration (AUClast)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Area Under The Serum Concentration-Time Curve From Time 0 To 12 Hours Postdose (AUC0-12)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
AUC From Time 0 to Infinity (AUC0-inf)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Elimination Half-life (t1/2)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Apparent Clearance (CL/F)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose of Day 1
Title
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Percentage of the AUC0-∞ That Is Due To the Extrapolation (%AUCext)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Terminal Elimination Rate (Lambda-z)
Time Frame
Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1
Title
Participants With Severe Neutropenia
Description
Count of participants who had an incidence of severe neutropenia, defined as any value of absolute neutrophil count (ANC) <0.5 * 10^9/L at any time.
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Duration of Severe Neutropenia
Description
The duration of severe neutropenia was derived by counting the number of days with absolute neutrophil count (ANC) values <0.5 * 10^9/L.
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Area Under The Serum Drug Concentration By Time Curve Of Absolute Neutrophil Count (AUC ANC)
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Absolute Neutrophil Count (ANC) Nadir
Description
ANC nadir (measured in 10^9/L) is the lowest ANC recorded.
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Tbo-filgrastim Administration
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Chemotherapy
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to ANC Recovery To ≥1.0 * 10^9/L From ANC Nadir
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to ANC Recovery To ≥2.0 * 10^9/L From ANC Nadir
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Tbo-filgrastim Administration
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Tbo-filgrastim Administration
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Chemotherapy
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Chemotherapy
Time Frame
ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)
Title
Participants With Febrile Neutropenia During the First Cycle of Chemotherapy
Description
Febrile neutropenia was defined as an axillary or external ear temperature >38.3°C (100.94°F) or 2 consecutive readings >37.8°C (100.04°F) at least 2 hours apart and an ANC <0.5 * 10^9/L. The efficacy variable was evaluated for up to 21 days from the start of the first cycle of chemotherapy.
Time Frame
(relative to tbo-filgrastim therapy) Days -7 to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Male or female infants, children and adolescents aged 1 month to <16 years.
Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
Body weight ≥5 kg.
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
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.
Normal cardiac, renal, and hepatic function.
All subjects must have a life expectancy of 12 weeks or more.
Performance Status: Lansky performance score >60 (age 1 to <16 years).
More criteria may apply, please contact the investigator for more information.
Exclusion:
Bone marrow involvement.
Active myelogenous leukemia or history of myelogenous leukemia.
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.
History of congenital neutropenia or cyclic neutropenia.
Pregnant or nursing female patients.
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.
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
More criteria may apply, please contact the investigator for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 12958
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Teva Investigational Site 12951
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Teva Investigational Site 12954
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Teva Investigational Site 12953
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Teva Investigational Site 12959
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Teva Investigational Site 12960
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Teva Investigational Site 12957
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Teva Investigational Site 59104
City
Sofia
ZIP/Postal Code
15257
Country
Bulgaria
Facility Name
Teva Investigational Site 59105
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Teva Investigational Site 60015
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Teva Investigational Site 60014
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Teva Investigational Site 60016
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Teva Investigational Site 51186
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Teva Investigational Site 51185
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Teva Investigational Site 51184
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Teva Investigational Site 53249
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Teva Investigational Site 53248
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Teva Investigational Site 53245
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Teva Investigational Site 53246
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Teva Investigational Site 53247
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Teva Investigational Site 52063
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Teva Investigational Site 52064
City
Cluj-Napoca, Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Teva Investigational Site 52065
City
Timisoara
ZIP/Postal Code
300383
Country
Romania
Facility Name
Teva Investigational Site 50282
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Teva Investigational Site 50281
City
Krasnodar
ZIP/Postal Code
350007
Country
Russian Federation
Facility Name
Teva Investigational Site 50284
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Teva Investigational Site 50280
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Teva Investigational Site 50283
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Teva Investigational Site 58147
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Teva Investigational Site 58145
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Teva Investigational Site 58148
City
Lviv
ZIP/Postal Code
79035
Country
Ukraine
Facility Name
Teva Investigational Site 58146
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Teva Investigational Site 58149
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
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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