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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01674855
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
14.9
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: DA-3031

PEG-G-CSF

Drug: PEG-G-CSF
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Other Names:
  • DA-3031

    		•
    Active Comparator: Leucostim®

    G-CSF

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of grade 4 neutropenia in cycle 1 [21 day]

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

    Secondary Outcome Measures

    1. ANC nadir in cycle 1 [21 day]

      ANC nadir means the lowest point of ANC count.

    2. Time to ANC recovery in cycle 1 [21 day]

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

    3. Incidence of febrile neutropenia [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 [126 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University GURO hospital Seoul Korea, Republic of 152-703

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    • Principal Investigator: JaeHong Seo, M.D., Korea University Guro Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01674855
    Other Study ID Numbers:
    • DA3031_NP_III
    First Posted:
    Aug 29, 2012
    Last Update Posted:
    Oct 1, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Dong-A ST Co., Ltd.
    PEG-G-CSF
    Additional relevant MeSH terms:
    Neutropenia
    Lenograstim

    Study Results

    No Results Posted as of Oct 1, 2014