An open-label, multi-center, long-term safety follow-up, roll-over study in patients who have completed a prior Novartis-sponsored capmatinib (INC280) study and are judged by the investigator to benefit from continued treatment with capmatinib

ovartis Farmacéutica, S.A.0 个研究点目标入组 60 人开始时间: 2017年4月4日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1.Patient is currently receiving treatment with INC280 monotherapy 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.
•2.Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
•3.Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
•4.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.
•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 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1.Patient has been previously permanently discontinued from INC280 study treatment in the parent study due to any reason.
•2.Patient currently has unresolved toxicities for which INC280 dosing has been interrupted in the parent study (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow INC280 dosing to resume).
•3.Pregnant or nursing (lactating) women.
•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 7 days after stopping treatment.
•Please refer to protocol for further details and additional exclusion criteria

发起方

ovartis Farmacéutica, S.A.