A Study of E7080 in Subjects With Solid Tumor

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eisai Inc. ( Eisai Co., Ltd. )

ClinicalTrials.gov Identifier:

NCT01268293

First received: December 28, 2010

Last updated: November 16, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2010

Last Updated Date

November 16, 2012

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To investigate the tolerability and safety of E7080 when administered orally on a once daily continuous dose schedule in subjects with solid tumors [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To investigate the number of subjects with adverse events [ Time Frame: Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01268293 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of E7080 in Subjects With Solid Tumor

Official Title ^ICMJE

A Phase 1 Study of E7080 in Subjects With Solid Tumor

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: 1

Intervention: Drug: E7080

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 addict
Pregnant or nursing subjects
Subjects who are participating in another clinical trial.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01268293

Other Study ID Numbers ^ICMJE

E7080-J081-105

Has Data Monitoring Committee

Not Provided

Responsible Party

Eisai Inc. ( Eisai Co., Ltd. )

Study Sponsor ^ICMJE

Eisai Co., Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tatsuya Sasaki

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

Information Provided By

Eisai Inc.

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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