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A Phase 1 Study of E7080 in Subjects With Solid Tumor

Phase 1
20 Years
Open (Enrolling)

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Trial Information

A Phase 1 Study of E7080 in Subjects With Solid Tumor

Inclusion 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 PS

- 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

- Pregnant or nursing subjects

- Subjects who are participating in another clinical trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To investigate the tolerability and safety of E7080 when administered orally on a once daily continuous dose schedule in subjects with solid tumors

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Tatsuya Sasaki

Investigator Role:

Study Director

Investigator Affiliation:

Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 2011

Completion Date:

July 2013

Related Keywords:

  • Cancer
  • Cancer