NeutropeniaPhase 1NCT02527746
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase 1 study testing F-627 and EC regimen in people with Neutropenia and Breast Cancer, run by EVIVE Biotechnology.
Trial summary
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Neutropenia, Breast Cancer
- What is being tested?
- F-627 and EC regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old.
- Female postoperative breast cancer patients who require adjuvant chemotherapy, and are planned to receive 4 cycles of EC chemotherapy;
- East Cooperative Oncology Group (ECOG) performance 0-1.
- Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 10^9/L prior to chemotherapy.
- Hepatic and renal function within the normal range;.
- Left ventricular ejection fraction (LVEF) > 50%.
- Willing to sign the informed consent form and able to comply with protocol requirements
Who cannot join
- Women in pregnancy or breastfeeding; Women of child-bearing potential have a positive pregnancy test result prior to the first dose;
- Life expectancy less than 12 months;
- Radiation therapy within 4 weeks prior to enrollment;
- Breast cancer patients who have received neoadjuvant chemotherapy before radical mastectomy;
- Prior bone marrow or stem cell transplant;
- With other malignant tumors other than breast cancer;
Show all 17Show fewer
- Have received granulocyte colony stimulating factor (G-CSF) treatment within 6 weeks prior to enrollment;
- Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical diagnosis, electrocardiograph (ECG) or other approaches;
- With any disease that may cause splenomegaly;
- With acute infection, chronic active Hepatitis B within 1 year (unless patients tested negative for HBsAg prior to enrollment), or Hepatitis C;
- History of tuberculosis (TB); history of TB exposure, unless negative for tuberculin test; TB patients undergoing treatment; or suspected TB evaluated by chest x-ray;
- Known human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS);
- With sickle cell anemia;
- With alcohol or drug abuse that may affect the compliance with the study;
- With known hypersensitivity to E. coli derived proteins, G-CSF, or excipients;
- Has received any other investigational drug within 4 weeks prior to enrollment;
- Patients with diseases or symptoms unsuitable for participating in the clinical trial based on the investigator's judgment;
About this study
Official title: A Single-Center, Open-Label, Dose-Escalation Phase I Clinical Trial of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein for Injection as an Adjuvant to Chemotherapy in Subjects With Breast Cancer
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.
Read the detailed description
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients receiving 4 cycles of EC (Epirubicin plus Cyclophosphamide) chemotherapy.
18 patients (6 patients each cohort) were assigned to three sequential doses cohort of F-627 at the dose of 80, 240 and 320 µg/kg. The patients received chemotherapy (100 mg/m^2 epirubicin and 600 mg/m^2 cyclophosphamide) administrated by i.v. injection on Day 1 and F-627 by s.c. injection on Day 3 of each cycle for 4 cycles. If no dose-limiting toxicity (DLT) was observed in 6 patients during first cycle, the next cohort was escalated.
Blood samples were collected for completed blood counts with differential, serum F-627 concentration and safety evaluation at different point following F-672 injection.
The decision to proceed to the next higher dose was made jointly by the sponsor's medical expert and the investigator based upon the review of safety data in the first cycle treatment.
- Conditions
- Neutropenia, Breast Cancer
- Being tested
- F-627, EC regimen
- Medical subject headings
- Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-627Drug
Also called Recombinant Human Granulocyte Colony Stimulating Factor (rh G-CSF) Fc fusion protein
F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.
EC regimenDrug
Also called Epirubicin + Cyclophosphamide
Epirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| F-627 80 µg/kg | Experimental | F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. Receives: Drug: F-627; Drug: EC regimen |
| F-627 240 µg/kg | Experimental | F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. Receives: Drug: F-627; Drug: EC regimen |
| F-627 320 µg/kg | Experimental | F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. Receives: Drug: F-627; Drug: EC regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Safety endpoints include incidence rate and severity of adverse events (AEs), laboratory measurements, physical examinations, vital signs, and performance status. Severity of AEs were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03 criteria.
Measured: Up to 4 cycles (about 84 days)
Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Tolerability should be assessed by dose-limiting toxicity (DLT). DLT is defined as any grade 3 or greater adverse event related to the investigational drug that observed in cycle 1 (21 days).
Measured: Up to 21 days
Secondary outcomes (13)
T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using enzyme linked immunosorbent assay (ELISA).
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
There are a total of 13 blood sampling time points in each cycle: pre-dose and 2, 6, 12, 24, 36, 48, 72, 96, 120, 144, 192, and 240 hr after dosing. Two additional sampling time points, 312 and 432 hr after dosing, are included for the 320 μg/kg cohort. Serum drug concentrations of F-627 at different time points will be determined using ELISA.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L)
For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle.
Measured: Up to 4 cycles (84 days)
Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L)
For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle.
Measured: Up to 4 cycles (84 days)
Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days)
For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle.
Measured: Up to 4 cycles (84 days)
Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days)
For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle.
Measured: Up to 4 cycles (84 days)
Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L)
For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle.
Measured: Up to 4 cycles (84 days)
Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir
For cycle 1, starting on day 3, oral temperature measurement and routine blood test (including ANC) will be performed daily until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle; for chemotherapy cycles 2-4 (day 3-day 21 of each chemotherapy cycle, i.e., day 24-day 84 of the study), starting on day 3, oral temperature measurement and routine blood test will be performed every other day until ANC recovers to no less than 1.0 × 10^9/L from nadir, and once every 3 days thereafter until the next cycle.
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 posted19 Aug 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVIVE Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Junning Cao, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527746
- Sponsor's protocol ID
- 2012-F-627-CH1
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2015
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Dose-Escalation Phase I Clinical Trial of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein for Injection as an Adjuvant to Chemotherapy in Subjects With Breast Cancer
- ClinicalTrials.gov ID
- NCT02527746
- Acronym / sponsor ID
- 2012-F-627-CH1
- Conditions
- Neutropenia, Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- EVIVE BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 23 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.
Detailed description
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients receiving 4 cycles of EC (Epirubicin plus Cyclophosphamide) chemotherapy.
18 patients (6 patients each cohort) were assigned to three sequential doses cohort of F-627 at the dose of 80, 240 and 320 µg/kg. The patients received chemotherapy (100 mg/m^2 epirubicin and 600 mg/m^2 cyclophosphamide) administrated by i.v. injection on Day 1 and F-627 by s.c. injection on Day 3 of each cycle for 4 cycles. If no dose-limiting toxicity (DLT) was observed in 6 patients during first cycle, the next cohort was escalated.
Blood samples were collected for completed blood counts with differential, serum F-627 concentration and safety evaluation at different point following F-672 injection.
The decision to proceed to the next higher dose was made jointly by the sponsor's medical expert and the investigator based upon the review of safety data in the first cycle treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| F-627 80 µg/kg | Experimental | Drug: F-627, Drug: EC regimenF-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. |
| F-627 240 µg/kg | Experimental | Drug: F-627, Drug: EC regimenF-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. |
| F-627 320 µg/kg | Experimental | Drug: F-627, Drug: EC regimenF-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years old.
- Female postoperative breast cancer patients who require adjuvant chemotherapy, and are planned to receive 4 cycles of EC chemotherapy;
- East Cooperative Oncology Group (ECOG) performance 0-1.
- Absolute neutrophil count (ANC) ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 10^9/L prior to chemotherapy.
- Hepatic and renal function within the normal range;.
Key exclusion criteria (17 listed)
- Women in pregnancy or breastfeeding; Women of child-bearing potential have a positive pregnancy test result prior to the first dose;
- Life expectancy less than 12 months;
- Radiation therapy within 4 weeks prior to enrollment;
- Breast cancer patients who have received neoadjuvant chemotherapy before radical mastectomy;
- Prior bone marrow or stem cell transplant;
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-627Also: Recombinant Human Granulocyte Colony Stimulating Factor (rh G-CSF) Fc fusion proteinF-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used. | Drug | F-627 240 µg/kg, F-627 320 µg/kg, F-627 80 µg/kg |
| EC regimenAlso: Epirubicin + CyclophosphamideEpirubicin 100 mg/m^2 (in vein) and Cyclophosphamide 600 mg/m^2 (in vein) on Day 1 of each cycle for 4 cycles. | Drug | F-627 240 µg/kg, F-627 320 µg/kg, F-627 80 µg/kg |
Primary outcome
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Time frame: Up to 4 cycles (about 84 days)
Safety endpoints include incidence rate and severity of adverse events (AEs), laboratory measurements, physical examinations, vital signs, and performance status. Severity of AEs were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03 criteria.
Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.
Time frame: Up to 21 days
Tolerability should be assessed by dose-limiting toxicity (DLT). DLT is defined as any grade 3 or greater adverse event related to the investigational drug that observed in cycle 1 (21 days).
13 secondary outcomes
T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L)
Time frame: Up to 4 cycles (84 days)
Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L)
Time frame: Up to 4 cycles (84 days)
Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days)
Time frame: Up to 4 cycles (84 days)
Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days)
Time frame: Up to 4 cycles (84 days)
Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L)
Time frame: Up to 4 cycles (84 days)
Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir
Time frame: Up to 4 cycles (84 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Junning Cao, Professor principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F-627 and EC regimen in people with Neutropenia and Breast Cancer, run by EVIVE Biotechnology.
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 7 inclusion and 17 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 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. (time frame: Up to 4 cycles (about 84 days)). The study lists 2 primary outcomes in all. 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 23 Feb 2024.