Chemotherapy Induced NeutropeniaPhase 3PEG-G-CSFNCT01674855
Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
A Phase 3 study testing PEG-G-CSF and G-CSF in people with Chemotherapy Induced Neutropenia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy Induced Neutropenia
- What is being tested?
- PEG-G-CSF and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Infective symptom before chemotherapy into this study
- Received systemic antibiotics within 72 hours of randomization into this study.
- HIV positive
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chemotherapy Induced Neutropenia
- Being tested
- PEG-G-CSF, G-CSF
- Keywords
- PEG-G-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-G-CSFDrug
Also called DA-3031
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
G-CSFDrug
Also called Leucostim®
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
| Study group | Role | What they receive |
|---|---|---|
| DA-3031 | Experimental | PEG-G-CSF Receives: Drug: PEG-G-CSF |
| Leucostim® | Active comparator | G-CSF Receives: Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of grade 4 neutropenia in cycle 1
Grade 4 neutropenia means the ANC count is less than 500/mm3.
Measured: 21 day
Secondary outcomes (4)
ANC nadir in cycle 1
ANC nadir means the lowest point of ANC count.
Measured: 21 day
Time to ANC recovery in cycle 1
ANC recovery means the ANC count is more than 2,000/mm3.
Measured: 21 day
Incidence of febrile neutropenia
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.
Measured: 126 day
Incidence of IV antibiotics administration
IV antibiotics administration means that antibiotics are administered through intravenous route.
Measured: 126 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeHong Seo, M.D., Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674855
- Sponsor's protocol ID
- DA3031_NP_III
- Acronym
- PEG-G-CSF
- Status last verified
- Sep 2014
- First submitted
- 19 Jan 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01674855
- Acronym / sponsor ID
- PEG-G-CSF / DA3031_NP_III
- Conditions
- Chemotherapy Induced Neutropenia
- Keywords
- PEG-G-CSF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-3031 | Experimental | Drug: PEG-G-CSFPEG-G-CSF |
| Leucostim® | Active comparator | Drug: G-CSFG-CSF |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-G-CSFAlso: DA-3031Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle | Drug | DA-3031 |
| G-CSFAlso: Leucostim®Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle | Drug | Leucostim® |
Primary outcome
Duration of grade 4 neutropenia in cycle 1
Time frame: 21 day
Grade 4 neutropenia means the ANC count is less than 500/mm3.
4 secondary outcomes
ANC nadir in cycle 1
Time frame: 21 day
Time to ANC recovery in cycle 1
Time frame: 21 day
Incidence of febrile neutropenia
Time frame: 126 day
Incidence of IV antibiotics administration
Time frame: 126 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JaeHong Seo, M.D. principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-G-CSF and G-CSF in people with Chemotherapy Induced Neutropenia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of grade 4 neutropenia in cycle 1 (time frame: 21 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.