Women, between 18 and 75 years of age that have been diagnosed with Stage I-III breast cancer and are scheduled to undergo chemotherapy. This is a prophylaxis for myleotoxic chemotherapy induced neutropenia. MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005
Conditions
Sponsors
Generon (Shanghai) Corporation Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 2) Females =18 years of age and =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1) Subject is <18 or =75 years of age. 2) Disease progression has occurred while receiving a taxane regimen. 3) Subject has undergone radiation therapy within 4 weeks of enrollment. 4) Subject has undergone bone marrow or stem-cell transplantation. 5) Subject has a history of prior malignancy other than breast cancer that is NOT in remission. 6) Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded. 7) Subject has had chemotherapy within 180 days of screening. 8) Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test. 9) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure. 10) Unwillingness to participate in the study. 11) Any underlying medical condition that, in the Investigator’s opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events. 12) Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less. 13) Any condition, which can cause splenomegaly. 14) Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease. 15) ALT, AST, alkaline phosphatase, total bilirubin =2.5x ULN. 16) Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C. 17) Women who are pregnant or breast-feeding. 18) Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder. 19) Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated. 20) Subjects with Sickle Cell disease 21) Subjects with known hypersensitivity to E.coli derived proteins‚ pegfilgrastim‚ filgrastim, or any other component of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to evaluate the efficacy of F-627 given as a single fixed dose (20 mg) pre-filled syringe as compared to Neulasta® standard dosing (6 mg) in the first chemotherapy cycle. ;Secondary Objective: - To assess safety in patients treated with the a fixed dose of F-627 identified in this protocol using the AE/SAE reporting, and other standard lab findings including hematology and blood chemistry, urinalysis, and symptoms including, but not limited to, bone and back pain. - Analysis of serum samples from cycles 2 to 4 to assess if antibodies to F-627 are present and, if present, to evaluate the biological effects. Antibodies of interest are the immunoglobulin (Ig) G and IgM antibodies;Primary end point(s): The primary efficacy endpoint of the study is the duration of grade 4 (severe) neutropenia, defined as the number of days in which the subject has had an ANC <0.5 × 10^9/L during cycle 1 of their chemotherapy treatment. ;Timepoint(s) of evaluation of this end point: Cycle 1, Day 2-21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For all secondary and additional analyses, the F-627 group will each be compared to the Neulasta group. The secondary efficacy endpoints of this study are as follows: • The duration of use of intravenous (IV) antibiotics (total across all chemotherapy cycles). • The duration of hospitalization for febrile neutropenia or any infection (total across all chemotherapy cycles). • The incidence of febrile neutropenia, considering all chemotherapy cycles. Febrile neutropenia is defined as a single oral temperature of =38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC <0.5 x 109/L on the same day. • The incidence of grade 4 neutropenia for chemotherapy cycle 1. • The incidence of use of IV antibiotics, considering all chemotherapy cycles. • The incidence of hospitalization for febrile neutropenia or any infection, considering all chemotherapy cycles. ;Timepoint(s) of evaluation of this end point: Study Day 1 to Day 84 | — |
Countries
Bulgaria, Hungary, Latvia, Romania, Russian Federation, Ukraine, United States
Contacts
Public ContactCall Center
Generon (Shanghai) Corporation Ltd.
Outcome results
None listed