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

NCT02527746 | Completed Phase 1 Results

• 1 other identifier: 2012-F-627-CH1
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neutropenia; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate the Safety of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.

  Safety endpoints include incidence rate and severity of adverse events (AEs), laboratory measurements, physical examinations, vital signs, and performance status. Severity of AEs were assessed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.03 criteria.

  Up to 4 cycles (about 84 days)

• Tolerability (Dose-limiting Toxicity) of F-627 for Injection in the Treatment of Female Postoperative Patients With Breast Cancer Who Require Adjuvant Chemotherapy.

  Tolerability should be assessed by dose-limiting toxicity (DLT). DLT is defined as any grade 3 or greater adverse event related to the investigational drug that observed in cycle 1 (21 days).

  Up to 21 days

Secondary Outcomes (13)

• T1/2 of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3

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

• Cmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3

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

• Tmax of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3

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

• Area Under Curve (AUC)0-t of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3

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

• Vz/F of F-627 in Each Dose Cohort in Cycle 1 and Cycle 3

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

Study Arms (3)

F-627 80 µg/kg

EXPERIMENTAL

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

Drug: F-627; Drug: EC regimen

F-627 240 µg/kg

EXPERIMENTAL

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

Drug: F-627; Drug: EC regimen

F-627 320 µg/kg

EXPERIMENTAL

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

Drug: F-627; Drug: EC regimen

Interventions

F-627 DRUG

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

Also known as: Recombinant Human Granulocyte Colony Stimulating Factor (rh G-CSF) Fc fusion protein

F-627 240 µg/kg; F-627 320 µg/kg; F-627 80 µg/kg

EC regimen DRUG

Epirubicin 100 mg/m\^2 (in vein) and Cyclophosphamide 600 mg/m\^2 (in vein) on Day 1 of each cycle for 4 cycles.

Also known as: Epirubicin + Cyclophosphamide

F-627 240 µg/kg; F-627 320 µg/kg; F-627 80 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 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• EVIVE Biotechnology: lead
• Fudan University: collaborator

MeSH Terms

Conditions

Neutropenia; Breast Neoplasms

Interventions

EC regimen

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Catrina Wang / Senior Medical Director
• Organization: Evivebiotech

catrina.wang@evivebiotech.com

021-61760866

Study Officials

• Junning Cao, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: July 23, 2015
• First Posted: August 19, 2015
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 23, 2024
• Results First Posted: February 23, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share