NCT02156388

Brief Summary

This study is designed to access the safety, tolerance and Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in patients with metastatic tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

May 28, 2014

Last Update Submit

February 22, 2016

Conditions

Chemotherapy-induced NeutropeniaMetastatic Tumors

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse event

    To evaluate the safety and tolerance of single SC injection of GW003 to Metastatic Tumors.

    Ia:up to 4weeks;Ib: up to 10weeks

Secondary Outcomes (4)

  • Duration of severe neutropenia(DSN)

    Ia: up to 3weeks;Ib: up to 6weeks.

  • Anti-GW003 antibody

    Ia: up to 28weeks;Ib: up to 34weeks.

  • half-life(consists of distribution half-life [t1/2α] and elimination half-life [t1/2β])

    Pre-dose、0.5h、1h、2h、3h、6h、9h、12h、24h、48h、72h、96h、120h、144h and 168h post-dose

  • area under the concentration-time curve (AUC)

    Pre-dose、0.5h、1h、2h、3h、6h、9h、12h、24h、48h、72h、96h、120h、144h and 168h post-dose

Study Arms (8)

Ia-GW003 50μg/kg

EXPERIMENTAL

2-3 subjects

Biological: GW003

Ia-GW003 150μg/kg

EXPERIMENTAL

2-3 subjects

Biological: GW003

Ia-GW003 300μg/kg

EXPERIMENTAL

3-6 subjects

Biological: GW003

Ia-GW003 400μg/kg

EXPERIMENTAL

3-6 subjects

Biological: GW003

Ia-GW003 500μg/kg

EXPERIMENTAL

3-6 subjects

Biological: GW003

Ia-GW003 600μg/kg

EXPERIMENTAL

3-6 subjects

Biological: GW003

Ib-GW003 150μg/kg

EXPERIMENTAL

6-8 subjects

Biological: GW003

Ib-GW003 300μg/kg

EXPERIMENTAL

6-8 subjects

Biological: GW003

Interventions

GW003BIOLOGICAL

freeze-dried powder；single SC injection

Ia-GW003 150μg/kgIa-GW003 300μg/kgIa-GW003 400μg/kgIa-GW003 500μg/kgIa-GW003 50μg/kgIa-GW003 600μg/kgIb-GW003 150μg/kgIb-GW003 300μg/kg

Eligibility Criteria

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

You may qualify if:

  • Patients with pathologically and/or cytologically-confirmed malignant tumor (phase Ia)
  • Breast-cancer or NSCLC patients are suitable for chemotherapy regimen of receiving docetaxel plus adriamycin and could finish two-cycles adjuvant chemotherapy on schedule
  • years to 65years
  • Patients with Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1 and living at least 6 months
  • No main organ dysfunction, adequate cardiac,hepatic,renal and bone marrow function
  • Adequate hematologic function (value in center laboratory as the standard); white blood cell count (WBC)≥4.0×109/L neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin (HGB)≥lOO g/L.
  • Adequate hepatic and renal function(value in center laboratory as the standard):
  • Women of childbearing age need to pregnancy test Prior to receive therapy and agree to use effective contraception throughout the study
  • Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily, have understood the purpose and procedures and could follow requirements of the study

You may not qualify if:

  • History of cardiopathy or with signs and symptoms
  • History of bone marrow transplant and/or stem cell transplant
  • Patients with acute infection, systemic anti-infection treatment within 72 hours of study
  • Prior participated in drug therapy, radiotherapy or surgery and other clinical trials within 4 weeks
  • Prior use of recombinant human G-CSF(rhG-CSF)、PEG-rhG-CSF or erythropoietin within 4 weeks of study
  • Patients with history of primary myeloid malignancy or myelodysplasia
  • Known hypersensitivity to test drugs, rhG-CSF or any other biologicals
  • Pregnant female or nursing mother
  • Known HIV positive or active hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • zhongsheng Tong

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 28, 2014

First Posted

June 5, 2014

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

December 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

CN(1)