NCT01923545

Brief Summary

This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared 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
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_2

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

July 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2013

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

10 months

First QC Date

August 13, 2013

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 in cycle 1

    21 day

  • Incidence of IV antibiotics administration in cycle 1

    21 day

Study Arms (3)

DA-3031 3.6mg

EXPERIMENTAL

PEG-G-CSF

Drug: PEG-G-CSF

DA-3031 6mg

EXPERIMENTAL

PEG-G-CSF

Drug: PEG-G-CSF

Leucostim®

ACTIVE COMPARATOR

G-CSF

Drug: G-CSF

Interventions

PEG-G-CSFDRUG

Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle

Also known as: DA-3031
DA-3031 3.6mgDA-3031 6mg
G-CSFDRUG

Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 1 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:

  • Diagnosis of stage II or III breast cancer
  • Age : ≥18, ≤70
  • TAC regimen as adjuvant therapy
  • 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:

  • Received any other investigational drugs within 30 days of informed consent date
  • Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date
  • Infective symptom before chemotherapy into this study
  • Pregnant or lactating women
  • Prior bone marrow or stem cell transplantation
  • Other malignancy history within 5 years
  • HIV positive
  • Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date
  • Prior chemotherapy

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 15, 2013

Study Start

July 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations

KR(1)