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Completed

NCT Number: NCT01674855

Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

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.

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Key information

Conditions

Chemotherapy Induced Neutropenia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University GURO hospital

Seoul, 152-703, South Korea

About this study

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PEG-G-CSF

Drug

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

Other names: DA-3031

G-CSF

Drug

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

Other names: Leucostim®

Primary outcomes

  1. Duration of grade 4 neutropenia in cycle 1

    Time frame: 21 day

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

Secondary outcomes

  1. ANC nadir in cycle 1

    Time frame: 21 day

    ANC nadir means the lowest point of ANC count.

  2. Time to ANC recovery in cycle 1

    Time frame: 21 day

    ANC recovery means the ANC count is more than 2,000/mm3.

  3. Incidence of febrile neutropenia

    Time frame: 126 day

    Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.

  4. Incidence of IV antibiotics administration

    Time frame: 126 day

    IV antibiotics administration means that antibiotics are administered through intravenous route.

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy

Acronym: PEG-G-CSF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2012
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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