JPRN-jRCT2031210531进行中（未招募）2 期
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Takeda-Sponsored Ixazomib Studies
Fukunaga Shinichi0 个研究点目标入组 31 人开始时间: 2021年12月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of treatment in the parent study or as agreed by the Takeda clinician/designee.
- •2.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; and
- •c.In the opinion of the investigator and approved by the Takeda medical monitor, the participant may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (e.g., response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (e.g., commercial supply).
- •3. Agree to continue to practice contraceptive methods as outlined in the parent study.
排除标准
- •1. The participant 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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