Clinical trial · Interventional
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Patients With Breast Cancer
NCT02725606CI-TRIAL-00029145unknownPhase 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)
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.
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 |
|---|---|---|---|
| GW003 | Biological | — | UNRESOLVED |
| Pegylated Recombinant Human G-CSF | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Pegylated Recombinant Human G-CSF
- description
- 100ug/kg 6 subjects (2 subjects per GW003 cohort)
- interventionNames
- Biological: Pegylated Recombinant Human G-CSF
- type
- EXPERIMENTAL
- label
- GW003 300ug/kg
- description
- 6-8 subjects
- interventionNames
- Biological: GW003
- type
- EXPERIMENTAL
- label
- GW003 650ug/kg
- description
- 6-8 subjects
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years to 70 years, female * Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide) * Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2 * Have no clinically significant impairment in cardiac, liver and kidney * Adequate hematologic, hepatic and renal function which should meet the following requirements: 1. Absolute neutrophil count(ANC)≥1.5 x 10\^9/L 2. Blood platelet(PLT)≥100 x 10\^9/L 3. Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN) 4. Total bilirubin(TBIL)≤1.5×ULN 5. Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN 6. Hemoglobin(Hb)\>9 g/dL 7. Alkaline phosphatase(ALP)≤1.5×ULN * Expected to comply with protocol * With urine human chorionic gonadotropin (hCG) negative * Signed informed consent Exclusion Criteria: * With acute infection * With history of bone marrow transplant and/or stem cell transplant * With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia * Received surgery within 3 weeks before chemotherapy * Received G-CSF within 4 weeks before involved in this study * Females who are pregnant or lactating * Participated in other clinical trials at the same time or within 4 weeks before screening * Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products * With cacoethic addiction such as drug abuse or alcoholism * With other cases which is not suitable for this study judged by investigator
References
Publications (0)
Data not yet available
No reference posted for this study.