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

Jiangsu T-Mab Biopharma Co.,Ltd1 site in 1 country30 target enrollmentMarch 2016

ConditionsChemotherapy-induced Neutropenia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chemotherapy-induced Neutropenia
Sponsor: Jiangsu T-Mab Biopharma Co.,Ltd
Enrollment: 30
Locations: 1
Primary Endpoint: Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Jiangsu T-Mab Biopharma Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

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:
•Absolute neutrophil count(ANC)≥1.5 x 10\^9/L
•Blood platelet(PLT)≥100 x 10\^9/L
•Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
•Total bilirubin(TBIL)≤1.5×ULN
•Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN

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

Outcomes

Primary Outcomes

Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03

Time Frame: 21days

Secondary Outcomes

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)
CD34+ count(21days)
Time to reach the maximum observed plasma concentration [Tmax](21days)
Incidence of severe neutropenia(21days)
Frequency of subjects with anti-GW003 antibody(21days)
Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf](21days)
Time to absolute neutrophil count(ANC) recovery(21days)
Absolute neutrophil count[ANC](21days)
Duration of severe neutropenia(DSN)(21days)
ANC nadir(21days)
Maximum observed maximum plasma concentration [Cmax](21days)