This study is designed to demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim and Neupogen for the reduction in duration of neutropenia and the incidence of febrile neutropenia, in subjects receiving chemotherapy. MedDRA version: 9.1 Level: LLT Classification code 10029354 Term: Neutropenia
Conditions
Interventions
Product Name: Granulocyte-colony stimulating factor (G-CSF)PLIVA/Mayne filgrastim
Pharmaceutical Form: Solution for injection
INN or Proposed INN: filgrastim
rG-CSF, PLIVA/Mayne filgrastim
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 240-
T
Sponsors
Hospira UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females =18 and =70 years of age; 2. Written Informed consent given; 3. Subjects with invasive breast cancer appropriate for treatment with doxorubicin and docetaxel combination therapy in the neo-adjuvant, adjuvant or first line metastatic treatment setting, who have not previously received treatment with anthracyclines or taxanes; 4. Any acute adverse effects of prior therapy must have resolved to = NCI CTCAE (Version 3.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1; 5. ECOG Performance Status 0 or 1 as determined on Day 1 of Cycle 1 prior to administration of chemotherapy; 6. Adequate bone marrow function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: * Hb=10 g/dL (transfusion permitted) * Absolute neutrophil count (ANC) =1.5 x 10 9/L (10 to the power of 9/L) * Platelets =100 x 10 9/L (10 to the power of 9/L); 7. Adequate renal and hepatic function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: * Creatinine 2.5 x ULN; or b) Alkaline phosphatase 6 months. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Chemotherapy within the 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1) (or a longer period depending on the defined characteristics of the agents used e.g., 6 weeks for mitomycin); 2. Radiotherapy within the 6 weeks prior to the first dose of chemotherapy, except for localised spot radiotherapy for bone metastases (Day 1 of Cycle 1) or any prior radiotherapy to the mediastinal/pericardial region; 3. Any prior radiotherapy to the mediastinal/pericardial region; 4. Any concurrent anti-cancer therapy, including endocrine therapy (with the exception of corticosteroids), immunotherapy and monoclonal antibody therapy. Concurrent treatment with bisphosphonates is also excluded unless the subject has been on a stable dose for four weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1); 5.Receipt of a non-registered, investigational agent as part of a clinical trial within 3 months prior to the first dose of chemotherapy (Day 1 of Cycle 1); 6.Receipt of a registered agent as part of a clinical trial if final study follow-up visit is within 30 days of start of chemotherapy (Day 1 of Cycle 1); 7.Prior bone marrow or stem cell transplant; 8.Any known myeloid abnormality (to include a pre-malignant myeloid condition or malignant condition); 9.Subjects who, in the Investigator’s opinion, have had extensive prior radiotherapy to a significant area of the bone marrow potentially affecting myelopoiesis; 10.Co-existing active infection, or received systemic anti-infectives for the treatment of infection within 72 hours prior to the first dose of chemotherapy (Day 1 of Cycle 1); 11.Significant cardiovascular disease as defined by: a.History of congestive heart failure requiring therapy; b.History of unstable angina pectoris or myocardial infarction within 6 months prior to screening; c.Presence of severe valvular heart disease; d.Presence of an arrhythmia requiring treatment; 12.Any co-existing medical condition that in the Investigator’s judgement will substantially increase the risk associated with the subject’s participation in the study; 13.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures; 14.Clinically symptomatic brain metastases (baseline computerized tomography (CT) or magnetic resonance imaging (MRI) scan of the brain required only if there is clinical suspicion of central nervous system metastases); 15.Known hypersensitivity to E. coli-delivered products or docetaxel or other drugs formulated with polysorbate 80; 16.Previously received any G-CSF; 17.Uncontrolled hypercalcaemia (>NCI CTCAE (Version 3.0) grade 1); 18.Second malignancy (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix); 19.Pregnant or breast-feeding women; 20.Concomitant treatment with lithium or lithium products; 21. Hereditary fructose intolerance; 22. Concurrent treatment with erythropoietin or prior treatment within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the efficacy, safety and tolerability of PLIVA/Mayne filgrastim and Neupogen. To compare the immunogenicity of PLIVA/Mayne filgrastim and Neupogen. ;Primary end point(s): The primary endpoint is DSN (in days) (ANC 38.5°C.;Main Objective: To demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim to Neupogen. | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Latvia, Poland, Spain, United Kingdom
Outcome results
None listed