Women, between 18 and 75 years of age that have been diagnosed with Stage II-IV breast cancer in the adjuvant or metastatic setting and are scheduled to undergo chemotherapy. This is a profilaxis for myleotoxic chemotherapy induced neutropenia. Subjects with a history of prior malignancy other than breast cancer may enter the study if the malignancy is in remission. and not receiving active treatment. MedDRA version: 19.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ
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 20
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 365 days of screening. 8) Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, 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. 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 = 2.5 upper limit of normal. 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 objective of the study is to evaluate the efficacy and safety of F-627 given as a single fixed dose pre-filled syringe in the subject’s first chemotherapy cycle in comparison to Placebo.;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 will be the duration of grade 4 (severe) neutropenia (ANC < 0.5 x 109/L) observed in chemotherapy cycle 1.;Timepoint(s) of evaluation of this end point: Cycle 1, Day 2-21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For all secondary analyses, the endpoints will be measured for each cycle as well as over all cycles. • The duration in days of grade 4 (severe) neutropenia (ANC 38.0°C (100.4°F) sustained for >1 hour and ANC < 0.5 x 109/L) for each chemotherapy cycle and over all cycles. • The incidence rates of grade 2, grade 3, and grade 4 neutropenia for all chemotherapy cycles. • The time in days to ANC recovery post nadir for each chemotherapy cycle and over all cycles; recovery defined as an ANC = 2.0 × 109/L after the expected ANC nadir. • The depth of the ANC nadir for each chemotherapy cycle and over all cycles. • The incidence rates of infections for each chemotherapy cycle and over all cycles. • The use of antibiotic and pain medications for each chemotherapy cycle and over all cycles. • ECG endpoints: Change-from-baseline heart rate, PR, QRS and QTcF intervals. Categorical outliers and T-wave morphology changes on treatment.;Timepoint(s) of evaluation of this end point: The duration in days of grade 4 (severe) neutropenia (ANC < 0.5 × 109/L) for chemotherapy cycles 2, 3, and 4, and over all cycles. l The duration in days of grade 3 (moderate) and grade 4 (severe) neutropenia (ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively) for chemotherapy cycles 2, 3, 4, and over all cycles l The duration in days of grade 2 (mild), grade 3 (moderate) and 4 (severe) neutropenia (ANC < 1.5 × 109/L) for each chemotherapy cycle and over all cycles. | — |
Countries
Hungary, Russian Federation, Ukraine, United States
Contacts
Public ContactCall Center
Generon (Shanghai) Corporation Ltd.
Outcome results
None listed