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

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ClinicalTrials.gov Identifier: NCT01674855
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE August 29, 2012
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ]
Grade 4 neutropenia means the ANC count is less than 500/mm3.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
  • ANC nadir in cycle 1 [ Time Frame: 21 day ]
    ANC nadir means the lowest point of ANC count.
  • Time to ANC recovery in cycle 1 [ Time Frame: 21 day ]
    ANC recovery means the ANC count is more than 2,000/mm3.
  • 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.
  • Incidence of IV antibiotics administration [ Time Frame: 126 day ]
    IV antibiotics administration means that antibiotics are administered through intravenous route.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • ANC nadir in cycle 1 [ Time Frame: 21 day ]
    ANC nadir means the lowest point of ANC count.
  • Time to ANC recovery in cycle 1 [ Time Frame: 21 day ]
    ANC recovery means the ANC count is more than 2,000/mm3.
  • Incidence of febrile neutropenia [ Time Frame: 126 day ]
    Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temparature is more than 38.3 degrees celsius.
  • Incidence of IV antibiotics adminstration [ Time Frame: 126 day ]
    IV antibiotics adminstration means that antibiotics are administered through intravenous route.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy Induced Neutropenia
Intervention  ICMJE
  • Drug: PEG-G-CSF
    Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
    Other Name: DA-3031
  • Drug: G-CSF
    Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
    Other Name: Leucostim®
Study Arms  ICMJE
  • Experimental: DA-3031
    PEG-G-CSF
    Intervention: Drug: PEG-G-CSF
  • Active Comparator: Leucostim®
    G-CSF
    Intervention: Drug: G-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 27, 2012)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01674855
Other Study ID Numbers  ICMJE DA3031_NP_III
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-A ST Co., Ltd.
Study Sponsor  ICMJE Dong-A ST Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JaeHong Seo, M.D. Korea University Guro Hospital
PRS Account Dong-A ST Co., Ltd.
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP