JPRN-UMIN000015820已完成1 期
A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients. - A phase I trial of 100mg/m2 docetaxel in advanced or recurrent breast cancer patients.
Okayama University Hospital Center for Innovative Clinical Medicine0 个研究点目标入组 6 人开始时间: 2014年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Patients with a history of hypersensitivity to Docetaxel, alcohol or any drug product containing Polysorbate 80 (2)Patients with a mental disease or patients who are incapable of participating in the trial due to psychiatric symptoms (3)Patients with any uncontrollable infection (e.g., fungi, virus, bacteria) (4)Patients with unstable or untreated metastasis in the central nervous system (5)Patients with any uncontrolled heart disease including cadiomyopathy, NYHA grade III or IV heart diseases, arrhythmia, unstable angina and myocardial infarction (6)Patients with a history of treatment with Docetaxel for advanced or recurrent breast cancer. However, patients with recurrent disease can participate if the disease recurred at least 6 months after receiving the last dose of Docetaxel in a pre- and/or post-operative adjuvant chemotherapy (7)Patients who cannot tolerate pretreatment with Dexamethasone because steroids are clinically contraindicated (8)Patients with a history of or concurrent malignant tumor (9)Patients positive for anti-human immunodeficiency virus antibody, those with active chronic type B or type C hepatitis. (10)Patients with concurrent peripheral neuropathy of CTCAE (v 4.0) grade 2 or higher (11)Women who are pregnant, possibly pregnant or are lactating (12)Premenopausal, possibly pregnant female patients or fertile male patients who do not agree to practice contraception using medically approved methods from 2 weeks before the start of administration of the investigational product to 120 days after the completion of administration of the investigational product (13)Patients who cannot continue the treatment under hospitalization for at least 15 days, beginning from the start of administration of the investigational product in the first course (14)Patients otherwise unsuitable for this clinical trial in the opinion of the investigator or subinvestigator
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