An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsoredceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib. - NA

OVARTIS FARMA S.P.A.0 个研究点目标入组 150 人开始时间: 2021年6月17日最近更新: 2021年8月17日

研究概览

暂无简介。

•- 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.
•Other protocol defined inclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 128
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•1. Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.
•2. 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.)
•3. 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.
•4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after stopping ceritinib treatment.
•5. Sexually active males unless they use a condom during intercourse while taking drug and
•for 3 months after stopping ceritinib and should not father a child for at least 3 months
•after the last dose of treatment. A condom is required to be used also by vasectomized
•men as well as during intercourse with a male partner in order to prevent delivery of the
•drug via seminal fluid.

发起方

OVARTIS FARMA S.P.A.