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Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer

Primary Purpose

Chemotherapy-induced Neutropenia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Pegylated Recombinant Human G-CSF
GW003
Sponsored by
Jiangsu T-Mab Biopharma Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Neutropenia focused on measuring Neutropenia, Breast Cancer, GW003

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Pegylated Recombinant Human G-CSF

GW003 300ug/kg

GW003 650ug/kg

GW003 850ug/kg

Arm Description

100ug/kg 6 subjects (2 subjects per GW003 cohort)

6-8 subjects

6-8 subjects

6-8 subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum observed maximum plasma concentration [Cmax]
Time to reach the maximum observed plasma concentration [Tmax]
Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf]
Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [AUC0-t]
Terminal elimination half-life[T1/2]
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.
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 to absolute neutrophil count(ANC) recovery
The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels.
Incidence of severe neutropenia
The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Duration of severe neutropenia(DSN)
Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
ANC nadir
The minimum value of ANC throughout the study period.
Frequency of subjects with anti-GW003 antibody
Anti-GW003 antibody will be detected pre-dose and 21d.

Full Information

First Posted
March 24, 2016
Last Updated
August 15, 2017
Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02725606
Brief Title
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu T-Mab Biopharma Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia
Keywords
Neutropenia, Breast Cancer, GW003

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pegylated Recombinant Human G-CSF
Arm Type
Active Comparator
Arm Description
100ug/kg 6 subjects (2 subjects per GW003 cohort)
Arm Title
GW003 300ug/kg
Arm Type
Experimental
Arm Description
6-8 subjects
Arm Title
GW003 650ug/kg
Arm Type
Experimental
Arm Description
6-8 subjects
Arm Title
GW003 850ug/kg
Arm Type
Experimental
Arm Description
6-8 subjects
Intervention Type
Biological
Intervention Name(s)
Pegylated Recombinant Human G-CSF
Intervention Description
subcutaneous
Intervention Type
Biological
Intervention Name(s)
GW003
Intervention Description
subcutaneous
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Maximum observed maximum plasma concentration [Cmax]
Time Frame
21days
Title
Time to reach the maximum observed plasma concentration [Tmax]
Time Frame
21days
Title
Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf]
Time Frame
21days
Title
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
Title
Terminal elimination half-life[T1/2]
Time Frame
21days
Title
Absolute neutrophil count[ANC]
Description
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
Title
CD34+ count
Description
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
Title
Time to absolute neutrophil count(ANC) recovery
Description
The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels.
Time Frame
21days
Title
Incidence of severe neutropenia
Description
The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Time Frame
21days
Title
Duration of severe neutropenia(DSN)
Description
Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Time Frame
21days
Title
ANC nadir
Description
The minimum value of ANC throughout the study period.
Time Frame
21days
Title
Frequency of subjects with anti-GW003 antibody
Description
Anti-GW003 antibody will be detected pre-dose and 21d.
Time Frame
21days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 Hemoglobin(Hb)>9 g/dL 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xichun Hu
Email
xchu2009@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guangfu Li
Email
guangfuli@t-mab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xichun Hu
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichun Hu
Email
xchu2009@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer

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