EUCTR2016-001681-28-ES进行中（未招募）1 期
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies.
Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited0 个研究点目标入组 22 人开始时间: 2016年9月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 22
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
- All
入选标准
- •Patients previously treated with ixazomib (excluding comparator or placebo patients not on current treatment with ixazomib) in a Millennium-sponsored study. Patients will be eligible to enter the rollover study when:
- •a.The parent study is closed or planned to be closed; and
- •b.The patient is on ixazomib monotherapy or on a drug combination with another medication, established while in his/her parent study; and
- •c.In the opinion of the investigator and confirmed by the Millennium medical monitor, the patient may continue to benefit from treatment with ixazomib (eg, response to therapy or stable disease without evidence of disease progression).
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •1. The patient meets any of the criteria for treatment discontinuation in the parent study.
- •2. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.
研究者
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