EUCTR2007-000394-36-LV进行中（未招募）不适用
A Phase III randomised, multicentre, double-blind, therapeutic equivalence study of biosimilar G-CSF (PLIVA/Mayne filgrastim) versus Neupogen (filgrastim-Amgen) in subjects receiving doxorubicin and docetaxel as a combination chemotherapy for breast cancer
Mayne Pharma Plc0 个研究点目标入组 279 人开始时间: 2007年7月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 279
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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 <1.5 x ULN
- •* Total bilirubin within normal reference range (unless elevation is known to be due to Gilbert's disease)
- •* Subjects must also meet one of the following criteria:
- •a) Alkaline phosphatase within normal reference range and both AST and ALT >2.5 x ULN; or
- •b) Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or
- •c) Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range;
- •8. Female subjects with reproductive potential must have a negative urine pregnancy test within 3 days prior to the first dose of chemotherapy (Day 1 of Cycle 1) and must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository);
- •9. Estimated life-expectancy >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
排除标准
- •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 concurrent anti-cancer therapy, including endocrine therapy, immunotherapy and monoclonal antibody therapy and any concurrent treatment with bisphosphonates unless the subject has been on a stable dose for four weeks prior to the first does of chemotherapy (Day 1 of Cycle 1);
- •4.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);
- •5.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);
- •6.Prior bone marrow or stem cell transplant;
- •7.Any known myeloid abnormality (to include a pre-malignant myeloid condition or malignant condition);
- •8.Subjects who, in the Investigator’s opinion, have had extensive prior radiotherapy to a significant area of the bone marrow potentially affecting myelopoiesis;
- •9.Co-existing active infection, or received systemic anti-infectives within 72 hours prior to the first dose of chemotherapy (Day 1 of Cycle 1);
- •10.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;
- •11.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;
- •12.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures;
- •13.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);
- •14.Known hypersensitivity to E. coli-delivered products or docetaxel or other drugs formulated with polysorbate 80 or intolerance to doxorubicin;
- •15.Previously received any G-CSF;
- •16.Uncontrolled hypercalcaemia (>NCI CTCAE (Version 3.0) grade 1);
- •17.Second malignancy (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix);
- •18.Pregnant or breast-feeding women;
- •19.Concomitant treatment with lithium or lithium products.
研究者
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