Phase 2
Completed N=50
A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement
Source: ClinicalTrials.gov NCT02190721 ↗Enrolled (actual)
50
Serious AEs
24.0%
Results posted
Jul 2018
Primary outcomePrimary: Participants With Adverse Events (AEs) — 2; 28; 16; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Adverse Events (AEs) |
2; 28; 16; 2; 28; 15 | — |
| PRIMARY Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results |
0; 3; 1; 0; 1; 1 | — |
| PRIMARY Participants With Potentially Clinically Significant Abnormal Hematology Results |
2; 6; 3; 1; 2; 0 | — |
| PRIMARY Participants With Potentially Clinically Significant Abnormal Vital Signs |
1; 23; 11; 0; 14; 9 | — |
| PRIMARY Participants With Potentially Clinically Significant Abnormal Electrocardiogram Results |
0; 0; 0 | — |
| PRIMARY Participants With Negative Shifts From Baseline to End of Study in Physical Exam Findings |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Participants With Injection Site Reactions to Tbo-Filgrastim Administration |
2; 7; 2; 2; 2; 0 | — |
| PRIMARY Participants With Negative Shifts From Baseline to End of Study in Spleen Sonography Findings |
0; 0; 0 | — |
| PRIMARY Participants Who Were Alive at the 90 Day Follow-Up |
2; 30; 18 | — |
| SECONDARY Participants With Positive Immunogenicity Findings Tested at Four Study Timepoints |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Tbo-Filgrastim |
26087.95; 20048.27; 19032.60 | — |
| SECONDARY Time to Maximum Observed Serum Concentration (Tmax) of Tbo-Filgrastim |
6.00; 4.07; 4.00 | — |
| SECONDARY Area Under The Serum Concentration-Time Curve From Time 0 To Time Of Last Quantifiable Concentration (AUClast) |
187889.69; 142124.91; 127447.08 | — |
| SECONDARY Area Under The Serum Concentration-Time Curve From Time 0 To 12 Hours Postdose (AUC0-12) |
187889.69; 144109.32; 140550.22 | — |
| SECONDARY AUC From Time 0 to Infinity (AUC0-inf) |
161964.32; 198470.33 | — |
| SECONDARY Elimination Half-life (t1/2) |
2.41; 2.52 | — |
| SECONDARY Apparent Clearance (CL/F) |
0.98; 1.68 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase (Vz/F) |
3.21; 6.13 | — |
| SECONDARY Percentage of the AUC0-∞ That Is Due To the Extrapolation (%AUCext) |
7.97; 8.19 | — |
| SECONDARY Terminal Elimination Rate (Lambda-z) |
.30; .29 | — |
| SECONDARY Participants With Severe Neutropenia |
1; 19; 6; 1; 11; 12 | — |
| SECONDARY Duration of Severe Neutropenia |
1.5; 2.5; 0.7 | — |
| SECONDARY Area Under The Serum Drug Concentration By Time Curve Of Absolute Neutrophil Count (AUC ANC) |
20.465; 53.931; 87.098 | — |
| SECONDARY Absolute Neutrophil Count (ANC) Nadir |
0.490; 0.851; 0.832 | — |
| SECONDARY Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Tbo-filgrastim Administration |
3.0; 6.9; 7.3 | — |
| SECONDARY Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Chemotherapy |
6.5; 10.3; 11.2 | — |
| SECONDARY Time to ANC Recovery To ≥1.0 * 10^9/L From ANC Nadir |
10.0; 2.2; 1.0 | — |
| SECONDARY Time to ANC Recovery To ≥2.0 * 10^9/L From ANC Nadir |
13.0; 3.0; 2.8 | — |
| SECONDARY Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Tbo-filgrastim Administration |
13.0; 7.3; 5.1 | — |
| SECONDARY Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Tbo-filgrastim Administration |
16.0; 8.1; 10.2 | — |
| SECONDARY Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Chemotherapy |
16.5; 10.2; 7.4 | — |
| SECONDARY Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Chemotherapy |
19.5; 11.0; 14.0 | — |
| SECONDARY Participants With Febrile Neutropenia During the First Cycle of Chemotherapy |
1; 9; 3; 1; 21; 15 | — |
Eligibility Criteria
Inclusion:
- Male or female infants, children and adolescents aged 1 month to 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.
Data sourced from ClinicalTrials.gov (NCT02190721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.