NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	solid tumor
Date of first enrollment	05/01/2011
Target sample size	18
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : E7080 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	To investigate the number of subjects with adverse events.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Subjects with histologically and/or cytologically diagnosis of solid tumor 2)Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available 3)Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia) 4)Subjects who completed previous anti-tumor therapy before at least 4 weeks 5)Subjects who are 20 years or older 6)Subjects with 0 to 1 of PS 7)Subjects agree to be hospitalized for DLT observation. 8)Subjects with adequate organ functions 9)Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration. 10)Agree to participate in this study in writing based on voluntary will
Exclude criteria	1)Subjects with brain metastasis accompanying clinical symptoms or requiring treatment 2)Subjects with the severe complication or disease history 3)Subjects unable to take oral medication. 4)Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study. 5)Scheduled for surgery during the projected course of the study. 6)Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test. 7)Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict 8)Pregnant or nursing subjects 9)Subjects who are participating in another clinical trial.