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Completed

NCT Number: NCT01923545

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

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.

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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 2

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 1 cycles of chemotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PEG-G-CSF

Drug

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

Other names: DA-3031

G-CSF

Drug

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

    Time frame: 21 day

    Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.

  4. Incidence of IV antibiotics administration in cycle 1

    Time frame: 21 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

Multi-Center, Randomized, Open, Phase II 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
2010
Primary completion
2011
Study completion
2011
First posted
Aug 15, 2013
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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