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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01674855
First received: January 19, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Chemotherapy Induced Neutropenia
Drug: PEG-G-CSF
Drug: G-CSF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]
    Grade 4 neutropenia means the ANC count is less than 500/mm3.


Secondary Outcome Measures:
  • ANC nadir in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]
    ANC nadir means the lowest point of ANC count.

  • Time to ANC recovery in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]
    ANC recovery means the ANC count is more than 2,000/mm3.

  • Incidence of febrile neutropenia [ Time Frame: 126 day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    IV antibiotics administration means that antibiotics are administered through intravenous route.


Estimated Enrollment: 74
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-3031
PEG-G-CSF
Drug: PEG-G-CSF
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Other Name: 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 Name: Leucostim®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674855

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01674855     History of Changes
Other Study ID Numbers: DA3031_NP_III
Study First Received: January 19, 2012
Last Updated: September 29, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Dong-A ST Co., Ltd.:
PEG-G-CSF

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014