An open-label, multi-center, roll-over study to assess long term safety of lenvatinib monotherapy or lenvatinib combination regimen or comparator treatment arm to cancer patients in Eisai sponsored lenvatinib trials

Eisai Ltd.0 个研究点目标入组 35 人开始时间: 2018年3月9日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•1. Provide signed written informed consent for the roll-over trial
•2. Currently enrolled in an Eisai sponsored lenvatinib clinical trial and still receiving at least one of the study drugs from that protocol
•3. Currently deriving clinical benefit from at least one of the study drug(s) as determined by the investigator
•4. Must be able and willing to comply with the current role-over protocol requirements
•5. Continued ability to swallow and retain orally administered study drug(s)
•6. Does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
•7. Women of childbearing potential and men with reproductive potential (if specified by the parent study) must be willing to continue to use highly effective methods of contraception control as per local practices of standard of care during the period of the study
•8. Women of childbearing potential must have a negative serum pregnancy test at the time of transition to the study and before continuing study drug(s)
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Permanent discontinuation of all study drug(s) in the parent trial due to toxicity or disease progression and without clinical benefit
•2. Receiving any prohibited medication(s) as described in the parent trial
•3. Any unresolved toxicity that meets the criteria for study drug(s) discontinuation or withdrawal criteria from the parent trial at the time of transition to this study
•4. Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to the roll-over trial that may interfere with assessment of toxicity
•5. Pregnant or lactating female
•6. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to the roll-over trial that could interfere with subject's safety in the opinion of the investigator

发起方

Eisai Ltd.