A Study of E7080 in Subjects With Solid Tumor

Eisai

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: E7080

Study type

Interventional

Funder types

Industry

Identifiers

NCT01268293

E7080-J081-105

Details and patient eligibility

About

The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors

Enrollment

9 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subjects with histologically and/or cytologically diagnosis of solid tumor
Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
Subjects who completed previous anti-tumor therapy before at least 4 weeks
Subjects who are 20 years or older
Subjects with 0 to 1 of Performance Status
Subjects agree to be hospitalized for DLT observation
Subjects with adequate organ functions
Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
Agree to participate in this study in writing based on voluntary will

Exclusion Criteria

Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
Subjects with the severe complication or disease history
Subjects unable to take oral medication.
Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
Scheduled for surgery during the projected course of the study.
Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
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
Pregnant or nursing subjects
Subjects who are participating in another clinical trial.