Clinical trial · Interventional
Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Multi-Center, Randomized, Open, Phase II Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy
NCT01923545CI-TRIAL-00015741PEG-G-CSFcompletedPhase 2ClinicalTrials.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 is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.
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 Induced Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-CSF | Drug | — | UNRESOLVED |
| PEG-G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DA-3031 3.6mg
- description
- PEG-G-CSF
- interventionNames
- Drug: PEG-G-CSF
- type
- EXPERIMENTAL
- label
- DA-3031 6mg
- description
- PEG-G-CSF
- interventionNames
- Drug: PEG-G-CSF
- type
- ACTIVE_COMPARATOR
- label
- Leucostim®
- description
- G-CSF
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of stage II or III breast cancer 2. Age : ≥18, ≤70 3. TAC regimen as adjuvant therapy 4. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1 5. Creatinine \< 1.5 x ULN 6. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN 7. Have given a written, informed consent Exclusion Criteria: 1. Received any other investigational drugs within 30 days of informed consent date 2. Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date 3. Infective symptom before chemotherapy into this study 4. Pregnant or lactating women 5. Prior bone marrow or stem cell transplantation 6. Other malignancy history within 5 years 7. HIV positive 8. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date 9. Prior chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.