Clinical trial · Interventional
Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Randomized, Open, Multi-Center, Phase III 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
NCT01674855CI-TRIAL-00015738PEG-G-CSFcompletedPhase 3ClinicalTrials.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 determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior 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 (2)
- type
- EXPERIMENTAL
- label
- DA-3031
- description
- PEG-G-CSF
- interventionNames
- Drug: PEG-G-CSF
- type
- ACTIVE_COMPARATOR
- label
- Leucostim®
- description
- G-CSF
- interventionNames
- Drug: G-CSF
Primary outcomes (1)
- measure
- Duration of grade 4 neutropenia in cycle 1
- timeFrame
- 21 day
- description
- Grade 4 neutropenia means the ANC count is less than 500/mm3.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age : ≥18, ≤70 2. Diagnosis of stage II, III or IV breast cancer 3. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1 4. Creatinine \< 1.5 x ULN 5. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN 6. Have given a written, informed consent Exclusion Criteria: 1. Prior chemotherapy 2. Prior bone marrow or stem cell transplantation 3. Other malignancy history within 5 years 4. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors 5. Received any other investigational drugs within 30 days of informed consent date 6. Radiation therapy within 4 weeks of informed consent date 7. Infective symptom before chemotherapy into this study 8. Received systemic antibiotics within 72 hours of randomization into this study. 9. HIV positive 10. Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.