jRCT2080222142已完成2 期
An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartissponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment
Novartis Pharma. K.K.1 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open Label, Multi Center
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Patient is currently enrolled in a Novartis- sponsored clinical study receiving nilotinib and has fulfilled all their requirements in the parent study.
- •Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator.
排除标准
- •Patient has been permanently discontinued from nilotinib study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
- •Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and is still receiving combination therapy.
- •Pregnant or nursing (lactating) women
结局指标
主要结局
-
long-term safety of nilotinib
次要结局
未报告次要终点
研究者
研究点 (1)
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