Clinical trial · Interventional
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
NCT02190721CI-TRIAL-00055473completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tbo-filgrastim | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tbo-filgrastim
- 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
- interventionNames
- Drug: tbo-filgrastim
Primary outcomes (9)
- measure
- Participants With Adverse Events (AEs)
- timeFrame
- 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)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.