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

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

Multi-Center, Randomized, Open, Phase II 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 examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared 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 1 cycles of chemotherapy.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

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. Diagnosis of stage II or III breast cancer
  2. Age : ≥18, ≤70
  3. TAC regimen as adjuvant therapy
  4. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
  5. Creatinine < 1.5 x ULN
  6. Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN
  7. Have given a written, informed consent

Exclusion Criteria:

  1. Received any other investigational drugs within 30 days of informed consent date
  2. Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date
  3. Infective symptom before chemotherapy into this study
  4. Pregnant or lactating women
  5. Prior bone marrow or stem cell transplantation
  6. Other malignancy history within 5 years
  7. HIV positive
  8. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date
  9. Prior chemotherapy

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
Experimental: DA-3031 3.6mg
PEG-G-CSF
Drug: PEG-G-CSF
Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle
Other Names:
  • DA-3031
Experimental: DA-3031 6mg
PEG-G-CSF
Drug: PEG-G-CSF
Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 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 1 cycle
Other Names:
  • Leucostim®

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 in cycle 1
Time Frame: 21 day
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.
21 day
Incidence of IV antibiotics administration in cycle 1
Time Frame: 21 day
IV antibiotics administration means that antibiotics are administered through intravenous route.
21 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

July 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 15, 2013

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_II

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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Locations

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