CTRI/2014/09/005007进行中（未招募）3 期
A Phase III, Randomized, Multicentric, Open-label, Equivalence Design Study to Compare theSafety and Efficacy of USV Pegfilgrastim and Neulasta®in Patients Receiving Doxorubicinand Docetaxel as a Combination Chemotherapy for Breast Cancer
SV Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female >=18 and <=65 years of age;
- •2.Patient who has provided written informed consent;
- •3. Chemotherapy naive patient with documented high risk stage II, or stage III or stage IV breast cancer (classification according to American Joint Committee on Cancer-AJCC;
- •4.Patient scheduled to receive chemotherapy comprising of docetaxel (75 mg/m2) and doxorubicin (60mg/m2) for their breast cancer disease;
- •5.Estimated life expectancy more than 6 months;
- •6. ECOG Performance [Appendix 5] Status <= 2 as determined within 7 days prior to Day 1 of Cycle 1 of chemotherapy;
- •7.Adequate bone marrow function, as determined within 7 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:
- •Hb >=9 g/dL (transfusion permitted during study);
- •ANC >=1.5 x 109/L (>=1500/mm³);
- •Platelet count >=100,000/μL (>=100 x 109/L).
- •8. Adequate renal and hepatic function, as determined within 7 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:
- •Creatinine <1.5 x Upper Limit of Normal (ULN);
- •Total bilirubin within normal reference range (unless elevation is known to be due to Gilbertâ??s disease);
- •Patients must also meet one of the following criteria:
- •Alkaline phosphatise (ALP) within normal reference range and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5 x ULN or
- •Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN or
- •Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range.
排除标准
- •1.Previous therapy with any Granulocyte-Colony Stimulating Factor (G-CSF) and Pegfilgrastim preparation;
- •2.Patients with history of severe chronic neutropenia (congenital, cyclic or
- •idiopathic);
- •3.Patients with history of chronic myeloid leukaemia or myelodysplastic syndrome;
- •4.Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in-situ carcinoma of cervix, or other solid tumour treated curatively and without evidence of recurrence for at least 2 years prior to study entry;
- •5.Patient who require concurrent radiotherapy or have radiotherapy within the 4 weeks prior to the first dose of chemotherapy, except for localized spot radiotherapy for bone metastases (Day 1 of Cycle 1)
- •6.Patient who is having concurrent anti-cancer therapy, including endocrine therapy (with the exception of corticosteroids at doses <=20 mg/day prednisolone or equivalent), immunotherapy, monoclonal antibody therapy and/or biological therapy;
- •7.Patient with chronic use of oral corticosteroids;
- •8.Concurrent treatment with bisphosphonates (unless the patient has been on a stable dose for four weeks prior to the first dose of chemotherapy [Day 1 of Cycle 1]);
- •9.Underlying neuropathy of grade 2 or higher;
- •10.Concurrent treatment with lithium;
- •11.Patients with prior bone marrow or stem cell transplantation;
- •12.Patients with leukocyte count more than 50 x 109/L;
- •13.Patients with cough, fever, dyspnoea in association with radiologic signs of pulmonary infiltrates at study entry;
- •14.Patient with clinically significant cardiac dysfunction at the time of screening, clinically significant findings on echocardiogram ( Ejection Fraction [EF] less than 50%) or a history of myocardial infarction or heart failure within 6 months preceding the first treatment cycle;
- •15.Brain metastases that are clinically symptomatic or being treated with steroids;
- •16.Patient with known hypersensitivity to E. Coli proteins or any of the excipients used in the test products;
- •17.Patients with rare hereditary problems of fructose intolerance, sickle cell disorders
- •18.Patients with positive serology for HIV1/2, Hepatitis B virus and/or Hepatitis C virus;
- •19.Pregnant or breast feeding women. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to Screening
- •20.Patient of childbearing potential unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients (or their partners) of childbearing potential regardless of whether a hormonal agent also is used as a method of contraception
- •21.Patient with known active drug addiction, including alcoholism;
- •22.Patient with systemic disease that may interfere with safety, compliance, response to the product under investigation or its evaluation;
- •23.Patient with co-existing active infection or have received systemic anti-infectives for the treatment of infection within 72 hours prior to the first dose of chemotherapy (Day 1 of Cycle 1);
- •24.Patient with symptomatic anaemia
研究者
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