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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
subcutaneous
subcutaneous
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGFrequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03
Time frame: 21days
Maximum observed maximum plasma concentration [Cmax]
Time frame: 21days
Time to reach the maximum observed plasma concentration [Tmax]
Time frame: 21days
Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf]
Time frame: 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]
Time frame: 21days
Terminal elimination half-life[T1/2]
Time frame: 21days
Absolute neutrophil count[ANC]
ANC will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.
Time frame: 21days
CD34+ count
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.
Time frame: 21days
Time to absolute neutrophil count(ANC) recovery
The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels.
Time frame: 21days
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Incidence of severe neutropenia
The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Time frame: 21days
Duration of severe neutropenia(DSN)
Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Time frame: 21days
ANC nadir
The minimum value of ANC throughout the study period.
Time frame: 21days
Frequency of subjects with anti-GW003 antibody
Anti-GW003 antibody will be detected pre-dose and 21d.
Time frame: 21days