NeutropeniaPhase 1/2NCT02522234
A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase 1/2 study testing F-627 240 μg/kg and F-627 320 μg/kg in people with Neutropenia, run by EVIVE Biotechnology at 1 site in China.
Trial summary
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer. The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Neutropenia
- What is being tested?
- F-627 240 μg/kg and F-627 320 μg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2014to 19 Aug 2015
- Phase
- Phase 1/2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- Female with breast cancer patients after resection who planned to receive up to 6 cycles of chemotherapy (docetaxol, doxorubicin and cyclophosphamide).
- Score 0-1 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%;
- Willing to provide written informed consent and to compliant study procedure.
Who cannot join
- Pregnancy or lactating women; female with pregnancy potential had positive pregnancy test prior to study treatment.
- Expected survival < 12 months.
- 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.
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- Patients received G-CSF treatment within 6 weeks prior to enrollment.
- Patient cann't tolerate the pre-treatment of chemotherapy.
- Acute congestive heart failure, myocardial disease, or myocardial infarction diagnosed by clinical, electrocardiography, or any other medical procedure.
- 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.
- 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.
- Known the positive result of human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS).
- 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 4 weeks prior enrollment.
- 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 Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of F-627 as Prophylaxis Therapy to TAC Chemotherapy in Women With Breast Cancer
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles.
Read the detailed description
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
This study was conducted at two centers in China and enrolled 15 patients with breast cancer receiving TAC chemotherapy (docetaxel, doxorubicin and cyclophosphamide). The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles. Patients will remain on study drug dose for each of the following 6 chemotherapy cycles.
Patients will remain on study drug dose for each of the following 6 chemotherapy cycles. The blood sampling will be collected for F-627 serum concentration analysis in cycle of 1 and 3.
- Conditions
- Neutropenia
- Being tested
- F-627 240 μg/kg, F-627 320 μg/kg
- Keywords
- Neutropenia, Chemotherapy
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-627 240 μg/kgBiological
Also called rh G-CSF Fc Fusion Protein
F-627 at 240 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle（21 days） of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 240 μg/kg arm. And the arm should contain 6 evaluable subjects.
F-627 320 μg/kgBiological
Also called rh G-CSF Fc Fusion Protein
F-627 at 320 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle（21 days） of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 320 μg/kg arm. The arm should contain 6 evaluable subjects.
| Study group | Role | What they receive |
|---|---|---|
| F-627 240 µg/kg | Experimental | F-627 at the dose of 240 mcg/kg administered by s.c. injection on Day 2 of each cycle for up to 6 cycles.
Chemotherapy (docetaxol, doxorubicin and cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for up to 6 cycles. Receives: Biological: F-627 240 μg/kg |
| F-627 320 µg/kg | Experimental | F-627 at the dose of 320 mcg/kg administered by s.c. injection on Day 2 of each cycle for 6 cycles.
Chemotherapy (docetaxol, doxorubicin and cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for up to 6 cycles. Receives: Biological: F-627 320 μg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events/abnormal laboratory value as measure of safety
Number of participants with adverse events/abnormal laboratory value as measure of safety and tolerability of rh G-CSF Fc fusion protein (F-627) in female patients wiht breast cance receiving adjuvant chemotherapy.
Measured: Up to 6 cycles (about 126 days)
Secondary outcomes (4)
Parameter of Peak Plasma Concentration
Parameter of Peak Plasma Concentration as a measure of pharmacokinetics profile of F-627.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Parameter of Area Under Plasma Concentration versus Time Curve
Parameter of Area Under Plasma Concentration versus Time Curve as a measure of pharmacokinetics profile of F-627.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Parameter of Clearance
Parameter of Clearance as a measure of pharmacokinetics profile of F-627.
Measured: Cycle 1 and cycle 3 (each cycle was about 21 days)
Absolute Neutrophil Count changes over time
Absolute Neutrophil Count changes over time as measure of pharmacodynamics of F-627.
Measured: Up to 6 cycles (about 126 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 start25 Feb 2014
- Primary completion19 Aug 2015
- Study completion19 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVIVE Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University, Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Junning Cao, Professor, Principal investigator, Fudan Universtiy Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522234
- Sponsor's protocol ID
- SP-CDR-1-1301
- Status last verified
- Nov 2019
- First submitted
- 10 Aug 2015
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of F-627 as Prophylaxis Therapy to TAC Chemotherapy in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02522234
- Acronym / sponsor ID
- SP-CDR-1-1301
- Conditions
- Neutropenia
- Keywords
- Neutropenia, Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- EVIVE BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University, Sun Yat-sen University
- Study start
- 25 Feb 2014 (actual)
- Primary completion
- 19 Aug 2015 (actual)
- Study completion
- 19 Aug 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 study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles.
Detailed description
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
This study was conducted at two centers in China and enrolled 15 patients with breast cancer receiving TAC chemotherapy (docetaxel, doxorubicin and cyclophosphamide). The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles. Patients will remain on study drug dose for each of the following 6 chemotherapy cycles.
Patients will remain on study drug dose for each of the following 6 chemotherapy cycles. The blood sampling will be collected for F-627 serum concentration analysis in cycle of 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-627 240 µg/kg | Experimental | Biological: F-627 240 μg/kgF-627 at the dose of 240 mcg/kg administered by s.c. injection on Day 2 of each cycle for up to 6 cycles. Chemotherapy (docetaxol, doxorubicin and cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for up to 6 cycles. |
| F-627 320 µg/kg | Experimental | Biological: F-627 320 μg/kgF-627 at the dose of 320 mcg/kg administered by s.c. injection on Day 2 of each cycle for 6 cycles. Chemotherapy (docetaxol, doxorubicin and cyclophosphamide) administered by intravenous injection on Day 1 of each cycle for up to 6 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 with breast cancer patients after resection who planned to receive up to 6 cycles of chemotherapy (docetaxol, doxorubicin and cyclophosphamide).
- Score 0-1 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;
Key exclusion criteria (18 listed)
- Pregnancy or lactating women; female with pregnancy potential had positive pregnancy test prior to study treatment.
- Expected survival < 12 months.
- 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;
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-627 240 μg/kgAlso: rh G-CSF Fc Fusion ProteinF-627 at 240 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle（21 days） of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 240 μg/kg arm. And the arm should contain 6 evaluable subjects. | Biological | F-627 240 µg/kg |
| F-627 320 μg/kgAlso: rh G-CSF Fc Fusion ProteinF-627 at 320 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle（21 days） of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 320 μg/kg arm. The arm should contain 6 evaluable subjects. | Biological | F-627 320 µg/kg |
Primary outcome
Number of participants with adverse events/abnormal laboratory value as measure of safety
Time frame: Up to 6 cycles (about 126 days)
Number of participants with adverse events/abnormal laboratory value as measure of safety and tolerability of rh G-CSF Fc fusion protein (F-627) in female patients wiht breast cance receiving adjuvant chemotherapy.
4 secondary outcomes
Parameter of Peak Plasma Concentration
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Parameter of Area Under Plasma Concentration versus Time Curve
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Parameter of Clearance
Time frame: Cycle 1 and cycle 3 (each cycle was about 21 days)
Absolute Neutrophil Count changes over time
Time frame: Up to 6 cycles (about 126 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 21 Nov 2019.
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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 Universtiy Shanghai Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing F-627 240 μg/kg and F-627 320 μg/kg 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 7 inclusion and 18 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 21 Nov 2019. 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 combined 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.
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?
Number of participants with adverse events/abnormal laboratory value as measure of safety (time frame: Up to 6 cycles (about 126 days)). 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 21 Nov 2019.