NCT01674855

Brief Summary

This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

January 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

January 19, 2012

Last Update Submit

September 29, 2014

Conditions

Chemotherapy Induced Neutropenia

Keywords

PEG-G-CSF

Outcome Measures

Primary Outcomes (1)

  • Duration of grade 4 neutropenia in cycle 1

    Grade 4 neutropenia means the ANC count is less than 500/mm3.

    21 day

Secondary Outcomes (4)

  • ANC nadir in cycle 1

    21 day

  • Time to ANC recovery in cycle 1

    21 day

  • Incidence of febrile neutropenia

    126 day

  • Incidence of IV antibiotics administration

    126 day

Study Arms (2)

DA-3031

EXPERIMENTAL

PEG-G-CSF

Drug: PEG-G-CSF

Leucostim®

ACTIVE COMPARATOR

G-CSF

Drug: G-CSF

Interventions

PEG-G-CSFDRUG

Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle

Also known as: DA-3031
DA-3031
G-CSFDRUG

Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle

Also known as: Leucostim®
Leucostim®

Eligibility Criteria

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

You may qualify if:

  • Age : ≥18, ≤70
  • Diagnosis of stage II, III or IV breast cancer
  • ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
  • Creatinine \< 1.5 x ULN
  • Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN
  • Have given a written, informed consent

You may not qualify if:

  • Prior chemotherapy
  • Prior bone marrow or stem cell transplantation
  • Other malignancy history within 5 years
  • Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
  • Received any other investigational drugs within 30 days of informed consent date
  • Radiation therapy within 4 weeks of informed consent date
  • Infective symptom before chemotherapy into this study
  • Received systemic antibiotics within 72 hours of randomization into this study.
  • HIV positive
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University GURO hospital

Seoul, 152-703, South Korea

Location

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor, humanGranulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • JaeHong Seo, M.D.

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

August 29, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

KR(1)