This is a randomized open label dose finding study to evaluate the efficacy and safety of
F-627 on women with Stage II-III breast cancer receiving chemotherapy treatment.
This is a randomized, multi-center, dose finding, open label, positive controlled Phase II
study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta®
(pegfilgrastim) in women with breast cancer who are receiving myelotoxic TC chemotherapy
(Taxotere (docetaxel) + cyclophosphamide).
The primary objective of this study is to evaluate the efficacy and safety of various single
cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in
breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study
will be defined by the duration of moderate neutropenia; the number of days in which the
patient has had an absolute neutrophil count (ANC) < 1.0 × 10^9/L during the first cycle of
their chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by
definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to
be tested are 80 µg/kg/dose, 240 µg/kg/dose, and 320 µg/kg/dose.
- Show evidence of a signed (personally or by a legally acceptable representative) and
dated informed consent document indicating that the patient has been informed of all
pertinent aspects of the trial.
- Females ≥ 18 years of age.
- Diagnosed with Stage II-III breast cancer.
- Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®,
doxorbucin and cyclophosphamide, 75, 50 and 600 mg/m2, respectively).
- ECOG Performance status of ≤ 2.
- White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet
count ≥ 150 × 109/L.
- Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST,
alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of
normal (ULN). Serum creatinine should be less than 1.7x ULN.
- All subjects must agree to use at least one of the following types of contraception:
intrauterine device, implantable progesterone device, progesterone intramuscular
injection, or oral contraceptive, which has been started at least one month prior to
visit one and will continue for the duration of the trial. The contraceptive patch
or condom use with spermicide are also acceptable forms of contraception as long as
they will be used continually throughout the duration of the trial.
- Subject is <18 or ≥ 75 years of age.
- Disease progression has occurred while receiving a taxane regimen.
- Subject has undergone radiation therapy within 4 weeks of enrollment.
- Subject has undergone bone marrow or stem-cell transplantation.
- Subject has a history of prior malignancy other than breast cancer.
- Subjects that have used G-CSF within 6 weeks of the screening period are also
- Subject has had chemotherapy within 365 days of screening
- Subject has documented congestive heart failure, cardiomyopathy or myocardial
infarction by clinical diagnosis, ECG test, or any other relevant test.
- History of alcohol or drug abuse that would interfere with the ability to be
compliant with the study procedure.
- Unwillingness to participate in the study.
- 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.
- Receiving other investigational drugs or biologics within 1 month or five half lives
- Any condition, which can cause splenomegaly.
- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel
- ALT, AST, alkaline phosphatase > 2.5 upper limit of normal.
- Patients 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.
- Women who are pregnant or breast-feeding.
- Patients known to be seropositive for HIV, or who have had an AIDS defining illness
or a known immunodeficiency disorder.
- Patients 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.
- Subjects with Sickle Cell disease
- Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim'
filgrastim, or any other component of the study drug.