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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01674855
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Neutropenia Drug: PEG-G-CSF Drug: G-CSF Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DA-3031
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Other Name: DA-3031

Active Comparator: Leucostim®
Drug: G-CSF
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
Other Name: Leucostim®

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01674855

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Korea, Republic of
Korea University GURO hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Dong-A ST Co., Ltd.
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Principal Investigator: JaeHong Seo, M.D. Korea University Guro Hospital
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Responsible Party: Dong-A ST Co., Ltd. Identifier: NCT01674855    
Other Study ID Numbers: DA3031_NP_III
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Keywords provided by Dong-A ST Co., Ltd.:
Additional relevant MeSH terms:
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Leukocyte Disorders
Hematologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs