CTRI/2012/01/002338已完成3 期
An Open-Label, Multi-Center, Randomized, Comparative, Clinical Study to Assess Efficacy and Safety of Lupinâ??s Pegfilgrastim Versus Amgenâ??s Neulastim® as an Adjunct to Chemotherapy in Patients with Non-Myeloid Malignancies.
upin Limited Biotechnology Division0 个研究点目标入组 170 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
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. Male or non-pregnant / non-lactating female patients between 18-75 years of age.
- •3. Patients with histologically or cytologically confirmed nonmyeloid malignancies (Breast cancer, Non-Small Cell Lung Cancer, Non-Hodgkinâ??s Lymphoma, Head and neck cancer,
- •Ovarian cancer, Bladder cancer)
- •4. Patients who are planned and eligible to receive myelosuppressive chemotherapy regimen that contains at least one chemotherapeutic agent from docetaxel/ paclitaxel/ doxorubicin/ epirubicin.
- •5. Patients who have not received myelosuppressive chemotherapy within last 12 months of screening.
- •6. Patients with baseline ANC of >= 1.5 x 109/L and platelet count >= 100 x 109/L
- •7. Patients with ECOG Performance status of 0 or 1
排除标准
- •1. Patients weighing 45 Kg
- •2. Patients with history of hypersensitivity to study drugs,components or similar products
- •3. Patients with myeloid malignancies and myelodysplasia
- •4. Patients currently receiving radiation therapy or have completed radiation therapy within 4 weeks before study entry
- •5. Patients with prior bone marrow or stem cell transplantation.
- •6. Patients with chronic use of oral corticosteroids. (Except <= 20 mg/day dose of prednisolone)
- •7. Patients with history of systemic antibiotic use within 72 hours prior to chemotherapy.
- •8. Patients with any active infection which may require systemic antimicrobial therapy
- •9. Patients who have received hematopoietic growth factors(e.g. G-CSF, pegGCSF, erythropoietin) or cytokines (e.g.
- •interleukins, interferons) within last 1 month of screening
- •10. Patients with inadequate hepatic and renal function [defined as Alkaline Phosphatase 2.5 X Upper limits of normal(ULN), serum SGOT 2.5 X ULN, SGPT 2.5 X ULN,Total bilirubin 1.5 X ULN and Creatinine 1.5 X ULN of the reference range at the screening assessment]
- •11. Patients with seropositivity for HIV or HBV or HCV
- •12. Known cases of Sickle Cell Anemia
- •13. Patients with radiographic evidence of active pulmonary infections and/or recent history of pneumonia within 1 month of screening.
- •14. Patients with clinically evident splenomegaly confirmed subsequently by ultrasonography.
- •15. 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]
- •16. 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.
- •17. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
- •18. Women of child-bearing potential & all men who are not willing to follow a reliable & effective contraceptive measure during the course of the study & at least 1 month
- •after the last visit.
- •19. Patients with Congestive Heart Failure Class III/IV as per NYHA Classification.
研究者
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