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Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Primary Purpose

Neutropenia, Breast Cancer

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

F-627

EC regimen

About this trial

This is an interventional treatment trial for Neutropenia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18-75 years old.
Female breast cancer patients after resection who planned to receive 4 cycles of adjuvant chemotherapy contains epirubicin and cyclophosphamide.
East Cooperative Oncology Group (ECOG) performance 0-1.
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 reference range.
Left ventricular ejection fraction (LVEF) > 50%.
Willing to provide written informed consent and to compliant study procedure.

Exclusion Criteria:

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 resection of breast cancer.
Patients received bone marrow or hemopoietic stem cell transplantation;
Patient was with metastatic cancer other than breast cancer.
Patients received Granulocyte Colony-stimulating Factor (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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

F-627 80 µg/kg

F-627 240 µg/kg

F-627 320 µg/kg

Arm Description

F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles.

F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles.

F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles.

Outcomes

Primary Outcome Measures

Number of participants with adverse events as measure of safety and tolerability of F-627 in female patients wiht breast cancer receiving adjuvant chemotherapy.

Secondary Outcome Measures

Maximum Plasma Concentration as a measure of pharmacokinetics profile of F-627.

Area Under the Curve as a measure of pharmacokinetics profile of F-627.

Clearance and Mean Residence Time as a measure of pharmacokinetics profile of F-627.

Absolute Neutrophil Count changes over time as measure of pharmacodynamics of F-627.

Full Information

NCT ID

NCT02527746

First Posted

July 23, 2015

Last Updated

August 17, 2015

Sponsor

EVIVE Biotechnology

Collaborators

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02527746

Brief Title

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Official Title

A Phase I, Single Center, Open-label, Dose Escalation Study of Recombinant Human Granulocyte Colony-stimulating Factor Fc Fusion Protein (F-627) in Breast Cancer Patient Receiving Adjuvant Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EVIVE Biotechnology

Collaborators

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A Phase I, dose escalation study to evaluation 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 evaluation the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients receiving 4 cycles of EC chemotherapy (Epirubicin plus Cyclophosphamide). 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/m2 epirubicin and 600 mg/m2 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 be made jointly by the sponsor's medical expert and the investigator based upon the review of safety data in the first cycle treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neutropenia, Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

F-627 80 µg/kg

Arm Type

Experimental

Arm Description

F-627 at the dose of 80 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles.

Arm Title

F-627 240 µg/kg

Arm Type

Experimental

Arm Description

F-627 at the dose of 240 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles.

Arm Title

F-627 320 µg/kg

Arm Type

Experimental

Arm Description

F-627 at the dose of 320 µg/kg administrated by s.c. injection on Day 3 of each cycle for 4 cycles.

Intervention Type

Biological

Intervention Name(s)

F-627

Other Intervention Name(s)

rh G-CSF Fc fusion protein

Intervention Description

F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.

Intervention Type

Drug

Intervention Name(s)

EC regimen

Other Intervention Name(s)

Epirubicin + Cyclophosphamide

Intervention Description

Epirubicin 100 mg/m2 (in vein) and Cyclophosphamide 600 mg/m2 (in vein) on Day 1 of each cycle for 4 cycles.

Primary Outcome Measure Information:

Title

Number of participants with adverse events as measure of safety and tolerability of F-627 in female patients wiht breast cancer receiving adjuvant chemotherapy.

Time Frame

Up to 4 cycles (about 84 days)

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration as a measure of pharmacokinetics profile of F-627.

Time Frame

Cycle 1 and cycle 3 (each cycle was about 21 days)

Title

Area Under the Curve as a measure of pharmacokinetics profile of F-627.

Time Frame

Cycle 1 and cycle 3 (each cycle was about 21 days)

Title

Clearance and Mean Residence Time as a measure of pharmacokinetics profile of F-627.

Time Frame

Cycle 1 and cycle 3 (each cycle was about 21 days)

Title

Absolute Neutrophil Count changes over time as measure of pharmacodynamics of F-627.

Time Frame

Up to 4 cycles (84 days)

Other Pre-specified Outcome Measures:

Title

Immunogenicity of F-627 by serum F-627 antibody analysis.

Time Frame

Up to 4 cycles (84 days)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-75 years old. Female breast cancer patients after resection who planned to receive 4 cycles of adjuvant chemotherapy contains epirubicin and cyclophosphamide. East Cooperative Oncology Group (ECOG) performance 0-1. 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 reference range. Left ventricular ejection fraction (LVEF) > 50%. Willing to provide written informed consent and to compliant study procedure. Exclusion Criteria: 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 resection of breast cancer. Patients received bone marrow or hemopoietic stem cell transplantation; Patient was with metastatic cancer other than breast cancer. Patients received Granulocyte Colony-stimulating Factor (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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junning Cao, Professor

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

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