A Study of E7080 in Subjects With Solid Tumor

Cancer Clinical Trial

Official title:

A Phase 1 Study of E7080 in Subjects With Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268293
• Other study ID #: E7080-J081-105
• Status: Completed
• Phase: Phase 1
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose Limiting Toxicity (DLT)		Up to 4 weeks
Primary	Number of Participants With Adverse Events	Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).	Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).