A Study of E7080 in Subjects With Solid Tumor

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

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Key information

Conditions

Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chuo-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E7080

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.

Primary outcomes

Number of Participants With Dose Limiting Toxicity (DLT)

Time frame: Up to 4 weeks
Number of Participants With Adverse Events

Time frame: 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).

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).

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study of E7080 in Subjects With Solid Tumor

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2013
First posted: Dec 30, 2010
Registry last updated: Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed