NL-OMON50344已完成4 期
An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartis-sponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment - TASIGNA Roll-over
ovartis Pharma BV0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
- 2 至 99（—）
入选标准
- •- Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical
- •Development & Medical Affairs 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 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
- •patient is still receiving combination therapy.
- •- Patients who are currently receiving treatment with any medications that have
- •the potential to prolong the QT interval or inducing Torsade de Pointes and the
- •treatment cannot be either safely discontinued at least one week prior to
- •nilotinib treatment or switched to a different medication prior to start of
- •nilotinib treatment and for the duration of the study (Please see Appendix 1
- •for a list of agents that prolong the QT interval).
- •- Pregnant or nursing (lactating) women or women of child-bearing potential
- •(for the definition see protocol page 19)
研究者
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