2024-511040-58-00招募中4 期
An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 10
- 主要终点
- Frequency and severity of AEs/SAEs
研究概览
简要总结
To evaluate long term safety data (SAEs and AEs ). Provide patients access to study drug after parent trials are concluded
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
- •Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
- •Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
- •Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
排除标准
- •Patient has been permanently discontinued from ceritinib study treatment in the parent study due to any reason.
- •Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ceritinib dosing to resume.)
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.
- •Sexually active males unless they use a condom during intercourse while taking drug and after stopping ceritinib and should not father a child in this period.
结局指标
主要结局
Frequency and severity of AEs/SAEs
Frequency and severity of AEs/SAEs
次要结局
- Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (10)
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