Chemotherapy-induced Neutropenia
Conditions
Keywords
Neutropenia, Breast Cancer, GW003
Brief summary
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.
Detailed description
This is an single-center, open-label, randomized, active-controlled phase I study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of GW003 in the breast cancer patients.GW003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein .It is a long-acting G-CSF(Granulocyte-Colony Stimulating Factor). In this study, participants will be administered a single dose of GW003. Every subject will only accept one dose. In addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of GW003 will be evaluated as well.
Interventions
BIOLOGICALPegylated Recombinant Human G-CSF
subcutaneous
BIOLOGICALGW003
subcutaneous
Sponsors
Jiangsu T-Mab Biopharma Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03 | 21days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach the maximum observed plasma concentration [Tmax] | 21days | — |
| Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf] | 21days | — |
| Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [AUC0-t] | 21days | — |
| Terminal elimination half-life[T1/2] | 21days | — |
| Absolute neutrophil count[ANC] | 21days | ANC will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose. |
| Maximum observed maximum plasma concentration [Cmax] | 21days | — |
| Time to absolute neutrophil count(ANC) recovery | 21days | The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels. |
| Incidence of severe neutropenia | 21days | The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03. |
| Duration of severe neutropenia(DSN) | 21days | Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03. |
| ANC nadir | 21days | The minimum value of ANC throughout the study period. |
| Frequency of subjects with anti-GW003 antibody | 21days | Anti-GW003 antibody will be detected pre-dose and 21d. |
| CD34+ count | 21days | CD34+ count will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose. |
Countries
China
Contacts
Primary ContactXichun Hu
Backup ContactGuangfu Li
Outcome results
None listed