NCT02725606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

March 24, 2016

Last Update Submit

August 15, 2017

Conditions

Chemotherapy-induced Neutropenia

Keywords

NeutropeniaBreast CancerGW003

Outcome Measures

Primary Outcomes (1)

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

    21days

Secondary Outcomes (12)

  • Maximum observed maximum plasma concentration [Cmax]

    21days

  • 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

  • +7 more secondary outcomes

Study Arms (4)

Pegylated Recombinant Human G-CSF

ACTIVE COMPARATOR

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

Biological: Pegylated Recombinant Human G-CSF

GW003 300ug/kg

EXPERIMENTAL

6-8 subjects

Biological: GW003

GW003 650ug/kg

EXPERIMENTAL

6-8 subjects

Biological: GW003

GW003 850ug/kg

EXPERIMENTAL

6-8 subjects

Biological: GW003

Interventions

Pegylated Recombinant Human G-CSFBIOLOGICAL

subcutaneous

Pegylated Recombinant Human G-CSF
GW003BIOLOGICAL

subcutaneous

GW003 300ug/kgGW003 650ug/kgGW003 850ug/kg

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

NeutropeniaBreast Neoplasms

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Xichun Hu

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu

CONTACT

xchu2009@hotmail.com

Guangfu Li

CONTACT

guangfuli@t-mab.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 1, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-01

Locations

CN(1)