ew Drug F-627 Treatment of Women with Breast Cancer Receiving Myelotoxic Chemotherapy
- Conditions
- 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: 19.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]MedDRA version: 19.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2016-001930-93-HU
- Lead Sponsor
- Generon (Shanghai) Corporation Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 120
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 < 75 years of age.
3) Diagnosed with Stage II-IV breast cancer.
4) Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
5) ECOG Performance status of = 2.
6) White Blood Cell count (WBC) = 4.0 × 109/L, hemoglobin = 11.5 g/dL and a platelet count = 150 × 109/L.
7) 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.
8) 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 is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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.<br>- 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 Outcome Measures
Name Time Method