CTRI/2009/091/001016已完成3 期
Randomized, comparative, Phase III clinical trial to compare the efficacy and safety of recombinant human pegylated granulocyte colony stimulating factor(Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in subjects with nonmyeloid malignancies receiving myelosuppressive chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
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
- •The subjects included in the study should satisfy the inclusion criteria enlisted
- •1. Adult subject of either sex between age group of 18 to 65 years with histologically confirmed non myeloid malignant tumors undergoing a variety
- •of myelosuppressive chemotherapy regimens
- •2. Cancer subject with a good performance status (ECOG grade 0-2)
- •3. Subjects with >= 20% risk of developing chemotherapy induced febrile neutropenia. Subjects receiving chemotherapy regimens with intermediate to high risk for febrile
- •neutropenia are eligible.
- •4. No serious abnormality of hepatic or renal function at screening.
- •5. Subject willing to sign the â??Informed Consent Formâ??
- •The following categories of subjects will be excluded from the study.
- •1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the
- •Investigator with or without specific investigations.
- •2. Subject with body weight < 45 kg
- •3. Current therapy with other investigational drugs or lithium.
- •4. History or clinical evidence of congestive heart failure.
- •5. Prior treatment with interferons, interleukins or colony stimulating factors
- •(including G-CSF, GM- CSF, M-CSF and erythropoietin).
- •6. Subject who has been receiving radiation therapy within 4 weeks of randomization into the study.
- •7. Prior bone marrow or stem cell transplantation
- •8. Pregnant women, nursing women and women not practicing effective contraception.
- •9. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.
排除标准
- •1. Subject with history or clinical evidence of serious benign medical illnesses
- •including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or
- •hematologic disease as determined by the clinical judgment of the
- •Investigator with or without specific investigations.
- •2. Subject with body weight < 45 kg
- •3. Current therapy with other investigational drugs or lithium.
- •4. History or clinical evidence of congestive heart failure (NYHA class III-IV).
- •5. Prior treatment with interferons, interleukins, or, colony stimulating factors
- •(including G-CSF, GM- CSF, M-CSF and erythropoietin).
- •6. Subject who has been receiving radiation therapy within 4 weeks of
- •randomization into the study.
- •7. Prior bone marrow or stem cell transplantation
- •8. Pregnant women, nursing women and women not practicing effective contraception.
- •9. Subject with known hypersensitivity to E-coli derived proteins or any
- •component of the study medication.
研究者
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