CTRI/2018/02/011914已完成4 期
An open-label, randomized, comparative, parallel group study to assess the Immunogenicity of Lupinâ??s Peg-filgrastim versus Neulasta® as an Adjunct to Chemotherapy in Patients with Breast Cancer.
upin Limited Biotechnology Division0 个研究点目标入组 138 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
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. Patients must be able and willing to give written informed consent prior to any study
- •related procedures
- •2. Ambulatory, female patients with an age ï?³18 years
- •3. Patients with histologically or cytologically proven diagnosis of breast cancer who are
- •eligible for neoadjuvant or adjuvant chemotherapy.
- •4. Patients who are planned and eligible to receive/ receiving myelosuppressive
- •chemotherapy regimen that contains at least one chemotherapeutic agent from
- •docetaxel/ paclitaxel / doxorubicin/ cyclophosphamide/ epirubicin
- •5. Patients who have not received any hematopoietic growth factors (e.g. G-CSF,
- •PegGCSF, erythropoietin) or cytokines (e.g. interleukins, interferons) anytime in the
- •6. Patients with baseline WBC greater than equal to LLN/ 3.5 x 109/L, ANC of greater than equal to 1.5 x 109/L, platelet count greater than equal to 100 x 109/L and hemoglobin greater than equal to 8.5 g/dL
- •7. Patients with ECOG Performance status of Lesser than equal to 2.
- •8. Patient who have estimated life expectancy of more than six months
- •9. No evidences of hemorrhage
排除标准
- •1. Male patients
- •2. Hypersensitivity to any of the study drugs or its components like E.coli proteins or
- •similar product.
- •3. Patients weighing less than 45 Kg
- •4. Patients with myeloid malignancies and myelodysplasia or evidence of metastatic
- •disease in bone marrow or brain
- •5. Patients currently receiving radiation therapy or have completed radiation therapy
- •within 4 weeks before study entry or likely to receive radiotherapy during the study
- •6. Patients with prior bone marrow or stem cell transplantation
- •7. Patients with chronic use of oral corticosteroids (Except less than equal to 20 mg/day dose of prednisolone/ equivalent steroids), immunotherapy, monoclonal antibody therapy and/or biological therapy or use of any other pegylated drug.
- •8. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy
- •9. Patients with any active infection which may require systemic antimicrobial therapy.
- •Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase
- •greater than 2.5 X Upper limits of normal (ULN), serum SGOT greater than 2.5 X ULN, SGPT greater than 2.5 X ULN, Total bilirubin greater than 1.5 X ULN and Creatinine greater than 1.5 X ULN of the reference range at the screening assessment]
- •10. Patients with seropositivity for HIV or HBV or HCV
- •11. Known cases of Sickle Cell Anemia
- •12. Patients with radiographic evidence of active pulmonary infections and/or recent
- •history of pneumonia within 1 month of screening
- •13. Patients with clinically evident splenomegaly confirmed subsequently by
- •ultrasonography
- •14. Patients with any other clinically significant disease(s) which, in the opinion of the investigator, could compromise the patientâ??s involvement in the study or overall
- •interpretation of the data. [for e.g. uncontrolled hematologic, renal, hepatic, endocrine, neurologic, psychiatric, metabolic, pulmonary, cardiovascular disease/impaired
- •functioning or history of any autoimmune disease]
- •15. Patients who have participated in another therapeutic clinical study within the past 30
- •days prior to screening, or are likely to simultaneously participate in another
- •therapeutic clinical study
- •16. Patients who are doubtful to comply with study procedures for mental, psychological
- •or social reasons.
- •Women of child-bearing potential who are not willing to follow a reliable & effective
- •contraceptive measure during the course of the study & at least 3 months after the last
- •dose of study drug.
- •18. Pregnant and Breast feeding women.
研究者
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