JPRN-jRCT2080221345
Unknown
Phase 1
A Phase 1 Study of E7080 in Subjects With Solid Tumor
Conditionssolid tumor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- solid tumor
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 18
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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