Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
This study is currently recruiting participants.
Verified August 2012 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01674855
First received: January 19, 2012
Last updated: August 30, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy Induced Neutropenia |
Drug: PEG-G-CSF Drug: G-CSF |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
cyclic neutropenia
Drug Information available for:
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]Grade 4 neutropenia means the ANC count is less than 500/mm3.
Secondary Outcome Measures:
- ANC nadir in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]ANC nadir means the lowest point of ANC count.
- Time to ANC recovery in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]ANC recovery means the ANC count is more than 2,000/mm3.
- Incidence of febrile neutropenia [ Time Frame: 126 day ] [ Designated as safety issue: Yes ]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 [ Time Frame: 126 day ] [ Designated as safety issue: No ]IV antibiotics administration means that antibiotics are administered through intravenous route.
| Estimated Enrollment: | 74 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DA-3031
PEG-G-CSF
|
Drug: PEG-G-CSF
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Other Name: 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 6 cycle
Other Name: Leucostim®
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674855
Contacts
| Contact: JiSoo Song, Manager | songjs@donga.co.kr |
Locations
| Korea, Republic of | |
| Korea University GURO hospital | Recruiting |
| Seoul, Korea, Republic of, 152-703 | |
| Contact: JaeHong Seo, M.D. cancer@korea.ac.kr | |
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | JaeHong Seo, M.D. | Korea University Guro Hospital |
More Information
No publications provided
| Responsible Party: | Dong-A Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01674855 History of Changes |
| Other Study ID Numbers: | DA3031_NP_III |
| Study First Received: | January 19, 2012 |
| Last Updated: | August 30, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Dong-A Pharmaceutical Co., Ltd.:
|
PEG-G-CSF |
Additional relevant MeSH terms:
|
Neutropenia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |
Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013