Clinical trial · Interventional
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients
A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients
NCT02963389CI-TRIAL-00036545completedPhase 1ClinicalTrials.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)
This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tripegfilgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients
- description
- A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
- interventionNames
- Drug: Tripegfilgrastim
- type
- EXPERIMENTAL
- label
- Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients
- description
- A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
- interventionNames
- Drug: Tripegfilgrastim
- type
- EXPERIMENTAL
- label
- Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * \>=6 and \<19-year-old pediatrics with solid tumor/lymphoma * Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC \< 0.5x10\^9/L * ANC \> 0.75x10\^9/L, platelet \> 75x10\^9/L * ECOG performance status 0 or 1 Exclusion Criteria: * Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases * History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins. * Women who are pregnant or lactating
References
Publications (2)
- DERIVEDLee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9. PMID 37559343
- DERIVEDLee S, Hong KT, Moon SJ, Choi JY, Hong CR, Shin HY, Cho JY, Jang IJ, Yu KS, Oh J, Kang HJ. Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors. Clin Pharmacol Ther. 2022 Jan;111(1):293-301. doi: 10.1002/cpt.2433. Epub 2021 Oct 27. PMID 34605552