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

Primary Purpose

Chemotherapy Induced Neutropenia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEG-G-CSF
G-CSF
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Neutropenia focused on measuring PEG-G-CSF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University GURO hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DA-3031

Leucostim®

Arm Description

PEG-G-CSF

G-CSF

Outcomes

Primary Outcome Measures

Duration of grade 4 neutropenia in cycle 1
Grade 4 neutropenia means the ANC count is less than 500/mm3.

Secondary Outcome Measures

ANC nadir in cycle 1
ANC nadir means the lowest point of ANC count.
Time to ANC recovery in cycle 1
ANC recovery means the ANC count is more than 2,000/mm3.
Incidence of febrile neutropenia
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
IV antibiotics administration means that antibiotics are administered through intravenous route.

Full Information

First Posted
January 19, 2012
Last Updated
September 29, 2014
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01674855
Brief Title
Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Acronym
PEG-G-CSF
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Neutropenia
Keywords
PEG-G-CSF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DA-3031
Arm Type
Experimental
Arm Description
PEG-G-CSF
Arm Title
Leucostim®
Arm Type
Active Comparator
Arm Description
G-CSF
Intervention Type
Drug
Intervention Name(s)
PEG-G-CSF
Other Intervention Name(s)
DA-3031
Intervention Description
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
Leucostim®
Intervention Description
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
Primary Outcome Measure Information:
Title
Duration of grade 4 neutropenia in cycle 1
Description
Grade 4 neutropenia means the ANC count is less than 500/mm3.
Time Frame
21 day
Secondary Outcome Measure Information:
Title
ANC nadir in cycle 1
Description
ANC nadir means the lowest point of ANC count.
Time Frame
21 day
Title
Time to ANC recovery in cycle 1
Description
ANC recovery means the ANC count is more than 2,000/mm3.
Time Frame
21 day
Title
Incidence of febrile neutropenia
Description
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.
Time Frame
126 day
Title
Incidence of IV antibiotics administration
Description
IV antibiotics administration means that antibiotics are administered through intravenous route.
Time Frame
126 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age : ≥18, ≤70 Diagnosis of stage II, III or IV breast cancer 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: Prior chemotherapy Prior bone marrow or stem cell transplantation Other malignancy history within 5 years Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors Received any other investigational drugs within 30 days of informed consent date Radiation therapy within 4 weeks of informed consent date Infective symptom before chemotherapy into this study Received systemic antibiotics within 72 hours of randomization into this study. HIV positive Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JaeHong Seo, M.D.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University GURO hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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