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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01674855 |
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Date of registration:
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19/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
PEG-G-CSF |
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Scientific title:
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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 |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01674855 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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JaeHong Seo, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korea University Guro Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chemotherapy Induced Neutropenia
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Intervention(s)
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Drug: G-CSF
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Drug: PEG-G-CSF
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Primary Outcome(s)
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Duration of grade 4 neutropenia in cycle 1
[Time Frame: 21 day]
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Secondary Outcome(s)
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Incidence of IV antibiotics administration
[Time Frame: 126 day]
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ANC nadir in cycle 1
[Time Frame: 21 day]
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Time to ANC recovery in cycle 1
[Time Frame: 21 day]
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Incidence of febrile neutropenia
[Time Frame: 126 day]
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Secondary ID(s)
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DA3031_NP_III
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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