EUCTR2007-000394-36-ES进行中（未招募）1 期
Estudio de fase III, aleatorizado, multicéntrico, doble ciego, deequivalencia terapéutica de un FEC-G biosimilar (filgrastim dePLIVA/Mayne) frente a Neupogen® (filgrastim de Amgen) en sujetos quereciben doxorubicina y docetaxel como terapia de combinación para elcáncer de mamaA 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 regimen for breast cancer.
Mayne Pharma Plc0 个研究点目标入组 279 人开始时间: 2007年11月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 109/L
- •Platelets =100 x 109/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 refernce 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 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 or intolerance to doxorubicin;
- •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 erythropoetin or prior treatment within 4 weeks prior to the first dose of chemotherapy (Day 1, Cycle 1).
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