A Study of E7080 in Subjects With Solid Tumor

NCT ID: NCT01268293

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-04-30

Brief Summary

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

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E7080

Intervention Type: DRUG

This arm will be a dose-escalation evaluation of 9-18 subjects 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). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.

Interventions

E7080

This arm will be a dose-escalation evaluation of 9-18 subjects 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). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatsuya Sasaki

Role: STUDY_DIRECTOR

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

Locations

Chuo-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

E7080-J081-105

Identifier Type: -

Identifier Source: org_study_id