Completed
PEG-G-CSFRandomized, 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
What is being tested
PEG-G-CSF
+ G-CSF
Drug
Who is being recruted
From 18 to 70 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: February 2012
Summary
Principal SponsorDong-A ST Co., Ltd.
Last updated: October 1, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorDong-A ST Co., Ltd.
Last updated: October 1, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
74 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
ANC >= 1,500/mm3, Platelet >= 100,000/mm3, ECOG : 0 or 1
Age : >= 18, <= 70
Creatinine < 1.5 x ULN
Diagnosis of stage II, III or IV breast cancer
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10 exclusion criteria prevent from participating
HIV positive
Infective symptom before chemotherapy into this study
Other malignancy history within 5 years
Pregnant or lactating women
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPEG-G-CSF
Group II
Active ComparatorG-CSF
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center