A Phase 1 Study of E7080 in Subjects With Solid Tumor

Phase 1

• Conditions: solid tumor

• Registration Number: JPRN-jRCT2080221345
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the number of subjects with adverse events.