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 - CLDK378A2X01B

ovartis Pharma AG0 个研究点目标入组 224 人开始时间: 2024年4月22日最近更新: 2024年7月22日

研究概览

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•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.

•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.

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