A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

NCT02522234 | Completed Phase 1

• 1 other identifier: SP-CDR-1-1301
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Neutropenia

Keywords

Neutropenia; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 cycles (about 126 days)

Secondary Outcomes (4)

• Parameter of Peak Plasma Concentration

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

• Parameter of Area Under Plasma Concentration versus Time Curve

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

• Parameter of Clearance

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

• Absolute Neutrophil Count changes over time

  Up to 6 cycles (about 126 days)

Other Outcomes (1)

• Immunogenicity of F-627

  Up to 6 cycles (about 126 days)

Study Arms (2)

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.

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.

Biological: F-627 320 μg/kg

Interventions

F-627 240 μg/kg BIOLOGICAL

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-627 240 µg/kg

F-627 320 μg/kg BIOLOGICAL

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

F-627 320 µg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• EVIVE Biotechnology: lead
• Fudan University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Junning Cao, Professor

  Fudan Universtiy Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: February 25, 2014
• Primary Completion: August 19, 2015
• Study Completion: August 19, 2015
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

CN (1)