A Phase 1/2 interventional study of F-627 240 μg/kg and F-627 320 μg/kg in Neutropenia, sponsored by EVIVE Biotechnology. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by EVIVE Biotechnology · Phase 1/2, Interventional, and Treatment
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.
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.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 15 is below the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →EVIVE Biotechnology is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: F-627 240 μg/kg
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.
Biological: F-627 320 μg/kg
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.
Also known as: 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.
Also known as: rh G-CSF Fc Fusion Protein
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.
Time frame: Up to 6 cycles (about 126 days)
Parameter of Peak Plasma Concentration
Parameter of Peak Plasma Concentration as a measure of pharmacokinetics profile of F-627.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 cycles (about 126 days)
Immunogenicity of F-627
Immunogenicity of F-627 by serum anti-F-627 antibody analysis.
Time frame: Up to 6 cycles (about 126 days)
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
EVIVE Biotechnology