EUCTR2012-004418-32-SE进行中（未招募）不适用
Cabazitaxel as salvage treatment for cisplatin-resistant germ cell cancer
Oslo University Hospital0 个研究点目标入组 29 人开始时间: 2014年9月19日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •· Male patients = 18 years old
- •· Histologically verified metastatic GCC (germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum)
- •· Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different platin-based
- •· ECOG Performance Status (PS): 0-2
- •· Life expectancy =3 months
- •· Adequate function of liver, kidneys and bone marrow at baseline
- •· Signed written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •· Systemic antitumor treatment within 21 days before study entry
- •· Simultaneous radiotherapy to the only target lesion
- •· Patients unwilling or unable to comply with the protocol
- •· Patients with unstable angina pectoris, myocardial infarction = 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias
- •· Patients with an active or uncontrolled infection
- •· Patients who have a history of another primary malignancy and are off treatment for = 3 years, with the exception of non-melanoma skin cancer
- •· Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above within 6 weeks
- •· Patients who have participated in another interventional clinical trial within 30 days before study entry
- •· Other serious medical conditions that could impair the ability of the patient to participate in the study
- •· Active infection requiring systemic antibiotic-, anti-viral-, or antifungal medication
- •· Neuropathy = Grade 2
- •· Patient with reproductive potential not implementing accepted and effective method of contraception during the whole study period and up to 6 months after the last dose of cabazitaxel.
- •· One or more of the following cabazitaxel-specific requirements:
- •- History of severe hypersensitivity reaction (= Grade 3) to docetaxel
- •- History of severe hypersensitivity reaction (= Grade 3) to polysorbate 80 containing drugs
- •- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
- •- Concurrent or planned treatment with OATP1B1 substrates within 12 hours before- or 3 hours after application of cabazitaxel
研究者
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