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

September 29, 2014 updated by: Dong-A ST Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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®
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of grade 4 neutropenia in cycle 1
Time Frame: 21 day
Grade 4 neutropenia means the ANC count is less than 500/mm3.
21 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ANC nadir in cycle 1
Time Frame: 21 day
ANC nadir means the lowest point of ANC count.
21 day
Time to ANC recovery in cycle 1
Time Frame: 21 day
ANC recovery means the ANC count is more than 2,000/mm3.
21 day
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.
126 day
Incidence of IV antibiotics administration
Time Frame: 126 day
IV antibiotics administration means that antibiotics are administered through intravenous route.
126 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3031_NP_III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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