EUCTR2016-001681-28-PL进行中（未招募）1 期
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Takeda-Sponsored Ixazomib Studies.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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 background therapy, and/or
- •comparator drugs (including placebo) in a Takeda-sponsored ixazomib
- •parent 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, a combination regimen with
- •ixazomib and other study medication(s), on a placebo combination, or on
- •an alternative arm regimen in a designated ixazomib parent study (ie,
- •Studies C16003, C16005, C16006, C16007,
- •C16008, C16010 Global, C16011, C16013, C16014 Global and Korean
- •Continuation, C16017, C16020, C16029, and C16047); and
- •c) In the opinion of the investigator and approved by the Takeda medical
- •monitor, the patient may continue to benefit from treatment with
- •ixazomib and/or another study drug/combination regimen (eg, response to therapy or stable disease without evidence of disease progression)
- •and has no alternate means to access the study drug(s) (eg, commercial
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
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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