JPRN-jRCT2031210131进行中(未招募)3 期
An open label, multi-center roll-over study to assess longterm safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment
Suzuki Kazuyuki0 个研究点目标入组 2 人开始时间: 2021年6月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 2
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
- ot applicable 至 ot applicable(—)
- 性别
- All
入选标准
- •Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
- •In the opinion of the Investigator would benefit from continued treatment.
排除标准
- •Patient has been previously permanently discontinued from study treatment in the parent protocol.
- •Patient's indication is commercially available and reimbursed in the local country.
- •Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
研究者
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