Phase 1
N=18
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Neutropenia · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02527746 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Feb 2024
Primary outcome: Primary: Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. — 6; 6; 6; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- F-627 (Drug); EC regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- EVIVE Biotechnology
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. |
6; 6; 6; 6; 6; 6 | — |
| PRIMARY Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy. |
0; 0; 0 | — |
| SECONDARY T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
49.88; 34.71; 56.37; 73.44; 61.95; 44.58 | — |
| SECONDARY Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
25.77; 226.80; 192.87; 29.06; 73.09; 85.17 | — |
| SECONDARY Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
24; 36.00; 48.15; 12.00; 9.10; 12.00 | — |
| SECONDARY Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
2477.75; 15230.79; 19858.38; 1586.35; 4347.35; 6556.98 | — |
| SECONDARY Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
2457.22; 1238.80; 1597.02; 6196.75; 6132.23; 4079.81 | — |
| SECONDARY Cl/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
31.34; 17.11; 18.89; 45.41; 62.45; 56.38 | — |
| SECONDARY Mean Residence Time (MRT)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3 |
86.85; 61.98; 88.69; 87.08; 75.61; 96.29 | — |
| SECONDARY Percentage of Subjects With Grade 3 or 4 Neutropenia (< 1.0 × 10^9/L) |
6; 3; 5; 0; 2; 0 | — |
| SECONDARY Percentage of Subjects With Grade 4 Neutropenia (< 0.5 × 10^9/L) |
3; 3; 2; 0; 0; 0 | — |
| SECONDARY Duration of Absolute Neutrophil Count (ANC)< 0.5 × 10^9/L (Days) |
0.8; 1.2; 0.5; 0; 0; 0 | — |
| SECONDARY Duration of Absolute Neutrophil Count (ANC)< 1.0 × 10^9/L (Days) |
2.8; 1.5; 1.5; 0; 0.3; 0 | — |
| SECONDARY Absolute Neutrophil Count (ANC) Nadir (10^9 Cells/L) |
0.50; 0.90; 0.72; 1.57; 1.97; 2.33 | — |
| SECONDARY Time (Days) of Absolute Neutrophil Count (ANC) Recovered to 1.0 × 10^9/L From Nadir |
2.5; 1.2; 1.0; 0.0; 0.7; 0.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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;
- 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;
Data sourced from ClinicalTrials.gov (NCT02527746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.