Clinical trial · Interventional
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy
NCT01238562CI-TRIAL-00009291FilgrastimcompletedPhase 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 study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).
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 |
|---|---|---|---|
| Chemotherapy Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| YPEG-Filgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- YPEG-Filgrastim, 10mcg/kg
- interventionNames
- Drug: YPEG-Filgrastim
- type
- EXPERIMENTAL
- label
- YPEG-Filgrastim, 20mcg/kg
- interventionNames
- Drug: YPEG-Filgrastim
- type
- EXPERIMENTAL
- label
- YPEG-Filgrastim, 30mcg/kg
- interventionNames
- Drug: YPEG-Filgrastim
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18～70yrs * Signed informed consent * Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin * Karnofsky score ≥70 * Life expectancy \>3 months * WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter * Normal coagulation function, no evidences of hemorrhage * Normal liver, heart, kidney function Exclusion Criteria: * Pregnant or lactating females * Proven active infectious diseases (e.g. viral hepatitis, TB) * Not adequately controlled infections * Known hypersensitivity to filgrastim or any other components of the study drug * Unstable or uncontrolled cardiac disease or hypertension * Currently participated in any other clinical trials * Patients with previous or expected to receive systemic radiotherapy * Evidence of metastatic disease in bone marrow, brain, et al * Alcoholic or drug abusers * Other conditions which in the opinion of the investigator preclude enrollment into the study
References
Publications (0)
Data not yet available
No reference posted for this study.