ISRCTN56891934已完成不适用
Dose-finding of a fixed dose XM22 in patients with breast cancer receiving 4 cycles of chemotherapy versus 6 mg Neulasta®
BioGeneriX AG (Germany)0 个研究点目标入组 200 人开始时间: 2008年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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
- 性别
- All
入选标准
- •1. Men and women aged >= 18 years
- •2. Signed and dated written informed consent
- •3. Breast cancer high risk stage II, or stage III or IV
- •4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
- •5. Chemotherapy-naïve
- •6. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •7. ANC >= 1.5 x 10^9/L
- •8. Platelet count >= 100 x 10^9/L
- •9. Adequate cardiac function (including left ventricular ejection fraction >= 50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation)
- •10. Adequate hepatic function, i.e., alanine aminotransferase (ALT)/aspartate transaminase (AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase <5 x ULN, bilirubin 11. Adequate renal function, i.e., creatinine <1.5 x
排除标准
- •1. Participation in a clinical trial within 30 days before randomisation
- •2. Previous exposure to filgrastim, pegfilgrastim, lenograstim, or other granulocyte-colony stimulating factors (G-CSFs) in clinical development
- •3. Known hypersensitivity to docetaxel
- •4. Underlying neuropathy of grade 2 or higher
- •5. Treatment with systemically active antibiotics within 72 hours before chemotherapy
- •6. Treatment with lithium
- •7. Chronic use of oral corticosteroids
- •8. Prior radiation therapy within 4 weeks before randomisation
- •9. Prior bone marrow or stem cell transplantation
- •10. Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix
- •11. Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint
- •12. Pregnant or nursing women. Women of child bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
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