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
- 试验地点
- 11
- 主要终点
- The primary efficacy end point will be the duration in days of the grade IV
研究概览
简要总结
Phase III, multicentric, randomized, open label, comparative study 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. Planned to be carried out in 11 centers, enrolling 108 subjects, this is to get a minimum of 88 evaluable subjects from seven centers. For each subject, the maximum duration of therapy with the study medication will be 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion: The subjects included in the study should satisfy the inclusion criteria enlisted below
- •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
- •Cancer subject with a good performance status (ECOG grade 0-2)
- •Subjects with ≥ 20% risk of developing chemotherapy induced febrile neutropenia.
- •Subjects receiving chemotherapy regimens with intermediate to high risk for febrile neutropenia are eligible.
- •No serious abnormality of hepatic or renal function at screening.
- •Subject willing to sign the “Informed Consent Form†Exclusion: The following categories of subjects will be excluded from the study.
- •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.
- •Subject with body weight < 45 kg
- •Current therapy with other investigational drugs or lithium.
- •History or clinical evidence of congestive heart failure.
- •Prior treatment with interferons, interleukins or colony stimulating factors (including G-CSF, GM- CSF, M-CSF and erythropoietin).
- •Subject who has been receiving radiation therapy within 4 weeks of randomization into the study.
- •Prior bone marrow or stem cell transplantation
- •Pregnant women, nursing women and women not practicing effective contraception.
- •Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.
排除标准
- •Subject with history or clinical evidence of serious benign medical illnessesincluding hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, orhematologic disease as determined by the clinical judgment of theInvestigator with or without specific investigations.
- •Subject with body weight < 45 kg
- •Current therapy with other investigational drugs or lithium.
- •History or clinical evidence of congestive heart failure (NYHA class III-IV).
- •Prior treatment with interferons, interleukins, or, colony stimulating factors(including G-CSF, GM- CSF, M-CSF and erythropoietin).
- •Subject who has been receiving radiation therapy within 4 weeks ofrandomization into the study.
- •Prior bone marrow or stem cell transplantation
- •Pregnant women, nursing women and women not practicing effective contraception.
- •Subject with known hypersensitivity to E-coli derived proteins or anycomponent of the study medication.
结局指标
主要结局
The primary efficacy end point will be the duration in days of the grade IV
时间窗: 10 days
neutropenia (defined as ANC ≤ 500 /mm3) in the present chemotherapy
时间窗: 10 days
cycle.
时间窗: 10 days
次要结局
- The secondary efficacy will be determined in terms of the following(secondary end points:)
研究者
研究点 (11)
Loading locations...
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