NeutropeniaPhase 2NCT02521441
A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
A Phase 2 study testing F-627 and Filgrastim in people with Neutropenia, run by EVIVE Biotechnology at 1 site in China.
Trial summary
This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Neutropenia
- What is being tested?
- F-627 and Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2014to 22 Dec 2015
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide written informed consent and to compliant study procedure.
- 18-70 years old;
- Female with breast cancer patients after resection who planned to receive up to 4 cycles of chemotherapy (epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively).
- Score 0-2 of East Cooperative Oncology Group (ECOG).
- Absolute neutrophil count (ANC) ≥ 2.0 × 109/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 109/L prior to chemotherapy.
- Liver and kidney function tests were within normal range.
- Left ventricular ejection fraction (LVEF) > 50%.
- If female, subject is either not of childbearing potential, or is of childbearing potential.
Who cannot join
- Patients received radiotherapy within 4 weeks prior to enrollment.
- Patients received neoadjuvant chemotherapy prior to the resection for breast cancer.
- Patients received bone marrow or hemopoietic stem cell transplantation.
- Patient was with malignancy other than breast cancer.
- Patients received G-CSF treatment within 6 weeks prior to enrollment.
- Acute congestive heart failure, myocardial disease, or myocardial infarction diagnosed by clinical, electrocardiography, or any other medical procedure.
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- Any disease that possibly cause splenomegaly.
- Acute infections, chronic active hepatitis B infection within 1 year (except subject with negative hepatitis B antigen prior to enrollment) or history of hepatitis C infection.
- Pregnancy or lactating women; female with pregnancy potential had positive pregnancy test prior to study treatment.
- Known the positive result of human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS).
- Patients with active tuberculosis (TB), or had ever the history of close contact with patients with TB except negative result in tuberculin test; or under TB treatment; or suspected TB by chest X-ray.
- Patients with sickle-cell anemia.
- Patients with alcohol abuse or drug addiction that may affect the compliance of the study.
- Patients with allergy to proteins extracted from Escherichia coli, G-CSF, or drug excipient.
- Patients took other investigational products within 1 month or 5 half-lives prior to the enrollment (longer time period is preferred) based on the mechanism of action.
- Patients with diseases or symptoms that may not be suitable to be enrolled in this study based on investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Open-label, Active-controlled, Dose Finding Study to Evaluate the Efficacy and Safety of F-627 Compared to Filgrastim in Women With Breast Cancer Receiving Myelotoxic Chemotherapy.
This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy.
Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.
Read the detailed description
This phase II study was conducted at 16 clinical centers in China and planned to enroll 150 women with breast cancer who will receive chemotherapy that includes up to 4 cycles of epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio on Day 1 of the study. Patients will remain on their randomized study drug dose and regimen for each of the following 3 chemotherapy cycles. The chemotherapy to be administered for chemotherapy cycles 2-4 should be the same therapy administered to the subject on Day1.
Chemotherapy will be administrated through intravenous IV) injection on Day 1 of each 21-day cycle and be repeated every 3 weeks for up to four cycles unless a dose delay is necessary. Approximately 48 hours after chemotherapy completion in cycle (day 3 of the cycle), patients will either receive a subcutaneous (SC) injection of F-627 (either 10 mg/dose or 20 mg/dose) or 5 μg/kg/dose filgrastim used up to two weeks or stopped while ANC more than 5 × 109/L.
To track ANC concentration post chemotherapy, subjects returned to their study site for blood draws either daily (Cycle 1) or 3 times per week (every other day; Cycles 2-4) until ANC levels reached ≥2.0 × 109/L, post-nadir, and then every 3 days until the next chemotherapy cycle.
All subjects returned for an End of Study visit approximately 3 weeks after their final study drug administration (Study Day 84) and had a follow-up phone call 30 days after the last study drug.
- Conditions
- Neutropenia
- Being tested
- F-627, Filgrastim
- Keywords
- Neutropenia, Myelotoxic Chemotherapy, G-CSF
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-627Biological
F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles.
FilgrastimBiological
Also called rh G-CSF
Filgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| F-627, 10 mg/dose | Experimental | F-627 at dose of 10 mg/dose administered by subcutaneous injection on Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles. Receives: Biological: F-627 |
| F-627, 20 mg/dose | Experimental | F-627 at dose of 20 mg/dose administered by subcutaneous injection on Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles. Receives: Biological: F-627 |
| Filgrastim, 5 mcg/kg/dose | Experimental | Filgrastim of 5 mcg/dose administered by subcutaneous injection for up to two weeks, start from Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles. Receives: Biological: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia post chemotherapy as measure of efficacy of F-627 compared to Filgrastim in female patients wiht breast cance receiving adjuvant chemotherapy.
Measured: In first of 4 cycles (21 days for each cycle) 84 days
Secondary outcomes (5)
The incidence rates of Grade 3 and Grade 4 neutropenia
The incidence rates of Grade 3 and Grade 4 neutropenia (ANC < 1.0 × 109/L and < 0.5 × 109/L, respectively) for all chemotherapy cycles.
Measured: up to 4 cycles (84 days)
The duration in days of Grade 3 and Grade 4 neutropenia for cycle 2 to 4.
The duration in days of Grade 3 and Grade 4 neutropenia (ANC <1.0 × 109/L and ANC <0.5 × 109/L, respectively) for cycle 2 to 4.
Measured: cycle 2-4 (63 days)
The incidence rates of febrile neutropenia
The incidence rates of febrile neutropenia (FN; defined as a decrease in neutrophils associated with fever) for each chemotherapy cycle.
Measured: Up to 4 cycles (84 days)
The depth of the ANC nadir
The depth of the ANC nadir for chemotherapy Cycles 1 to 4.
Measured: Up to 4 cycles (84 days)
Number of participants with adverse events, changes from baseline of laboratory
Number of participants with adverse events, changes from baseline of laboratory values as measure of safety of F-627 compared to Filgrastim in female patients with breast cancer receiving chemotherapy.
Measured: Up to 4 cycles (84 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start3 Jul 2014
- Primary completion20 Sep 2015
- Study completion22 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVIVE Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, The Affiliated Hospital of Qingdao University, Tongji Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, RenJi Hospital, Zhejiang Cancer Hospital, Yunnan Cancer Hospital, Henan Cancer Hospital, Jiangsu Provincial People's Hospital, Huaxi Hospital
- Responsible party
- Sponsor
- Investigators
- Jin Li, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521441
- Sponsor's protocol ID
- SP-CDR-1-1302
- Status last verified
- Feb 2018
- First submitted
- 10 Aug 2015
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ji D, Wang S, Yao W, Hou D, Wang X, Ye C, Li H, Yang H, Yi J, Lu J, Wang H, Xu X, Cai D, Liu X, Yan X, Nie J, Cui S, Jiang H, Cao J. Efbemalenograstim Alfa, an Fc Fusion Protein, Long-Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open-Label Trial. Clin Drug Investig. 2025 Nov;45(11):889-899. doi: 10.1007/s40261-025-01479-y. Epub 2025 Oct 9.
PubMed 41066031
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Active-controlled, Dose Finding Study to Evaluate the Efficacy and Safety of F-627 Compared to Filgrastim in Women With Breast Cancer Receiving Myelotoxic Chemotherapy.
- ClinicalTrials.gov ID
- NCT02521441
- Acronym / sponsor ID
- SP-CDR-1-1302
- Conditions
- Neutropenia
- Keywords
- Neutropenia, Myelotoxic Chemotherapy, G-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- EVIVE BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, The Affiliated Hospital of Qingdao University, Tongji Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, RenJi Hospital, Zhejiang Cancer Hospital, Yunnan Cancer Hospital, Henan Cancer Hospital, Jiangsu Provincial People's Hospital, Huaxi Hospital
- Study start
- 3 Jul 2014 (actual)
- Primary completion
- 20 Sep 2015 (actual)
- Study completion
- 22 Dec 2015 (actual)
- First posted
- 13 Aug 2015 (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 was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy.
Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.
Detailed description
This phase II study was conducted at 16 clinical centers in China and planned to enroll 150 women with breast cancer who will receive chemotherapy that includes up to 4 cycles of epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio on Day 1 of the study. Patients will remain on their randomized study drug dose and regimen for each of the following 3 chemotherapy cycles. The chemotherapy to be administered for chemotherapy cycles 2-4 should be the same therapy administered to the subject on Day1.
Chemotherapy will be administrated through intravenous IV) injection on Day 1 of each 21-day cycle and be repeated every 3 weeks for up to four cycles unless a dose delay is necessary. Approximately 48 hours after chemotherapy completion in cycle (day 3 of the cycle), patients will either receive a subcutaneous (SC) injection of F-627 (either 10 mg/dose or 20 mg/dose) or 5 μg/kg/dose filgrastim used up to two weeks or stopped while ANC more than 5 × 109/L.
To track ANC concentration post chemotherapy, subjects returned to their study site for blood draws either daily (Cycle 1) or 3 times per week (every other day; Cycles 2-4) until ANC levels reached ≥2.0 × 109/L, post-nadir, and then every 3 days until the next chemotherapy cycle.
All subjects returned for an End of Study visit approximately 3 weeks after their final study drug administration (Study Day 84) and had a follow-up phone call 30 days after the last study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| F-627, 10 mg/dose | Experimental | Biological: F-627F-627 at dose of 10 mg/dose administered by subcutaneous injection on Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles. |
| F-627, 20 mg/dose | Experimental | Biological: F-627F-627 at dose of 20 mg/dose administered by subcutaneous injection on Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles. |
| Filgrastim, 5 mcg/kg/dose | Experimental | Biological: FilgrastimFilgrastim of 5 mcg/dose administered by subcutaneous injection for up to two weeks, start from Day 3 of each cycle for up to 4 cycles. EC regimen (Epirubicin and Cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for 4 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to provide written informed consent and to compliant study procedure.
- 18-70 years old;
- Female with breast cancer patients after resection who planned to receive up to 4 cycles of chemotherapy (epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively).
- Score 0-2 of East Cooperative Oncology Group (ECOG).
- Absolute neutrophil count (ANC) ≥ 2.0 × 109/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 109/L prior to chemotherapy.
Key exclusion criteria (16 listed)
- Patients received radiotherapy within 4 weeks prior to enrollment.
- Patients received neoadjuvant chemotherapy prior to the resection for breast cancer.
- Patients received bone marrow or hemopoietic stem cell transplantation.
- Patient was with malignancy other than breast cancer.
- Patients received G-CSF treatment within 6 weeks prior to enrollment.
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 |
|---|---|---|
| F-627F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles. | Biological | F-627, 10 mg/dose, F-627, 20 mg/dose |
| FilgrastimAlso: rh G-CSFFilgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles. | Biological | Filgrastim, 5 mcg/kg/dose |
Primary outcome
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia
Time frame: In first of 4 cycles (21 days for each cycle) 84 days
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia post chemotherapy as measure of efficacy of F-627 compared to Filgrastim in female patients wiht breast cance receiving adjuvant chemotherapy.
5 secondary outcomes
The incidence rates of Grade 3 and Grade 4 neutropenia
Time frame: up to 4 cycles (84 days)
The duration in days of Grade 3 and Grade 4 neutropenia for cycle 2 to 4.
Time frame: cycle 2-4 (63 days)
The incidence rates of febrile neutropenia
Time frame: Up to 4 cycles (84 days)
The depth of the ANC nadir
Time frame: Up to 4 cycles (84 days)
Number of participants with adverse events, changes from baseline of laboratory
Time frame: Up to 4 cycles (84 days)
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 23 Feb 2018.
- Derived from this study: PubMed 41066031Ji D, Wang S, Yao W, Hou D, Wang X, Ye C, Li H, Yang H, Yi J, Lu J, Wang H, Xu X, Cai D, Liu X, Yan X, Nie J, Cui S, Jiang H, Cao J. Efbemalenograstim Alfa, an Fc Fusion Protein, Long-Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open-Label Trial. Clin Drug Investig. 2025 Nov;45(11):889-899. doi: 10.1007/s40261-025-01479-y. Epub 2025 Oct 9.
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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.
Jin Li, Professor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-627 and Filgrastim in people with Neutropenia, run by EVIVE Biotechnology at 1 site in China.
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 8 inclusion and 16 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 23 Feb 2018. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The duration of moderate or severe (grade 3 and 4, respectively) neutropenia (time frame: In first of 4 cycles (21 days for each cycle) 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521441, which also lists 1 linked publication.
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 23 Feb 2018.