A Study of E7080 in Subjects With Solid Tumor
This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: December 28, 2010
Last updated: February 21, 2015
Last verified: February 2014
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 1 Study of E7080 in Subjects With Solid Tumor
Primary Outcome Measures:
- Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
- 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). ] [ Designated as safety issue: Yes ]
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).
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01268293
Eisai Co., Ltd.
||Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
No publications provided
||Eisai Inc. ( Eisai Co., Ltd. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 28, 2010
|Results First Received:
||February 21, 2015
||February 21, 2015
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by Eisai Inc.:
ClinicalTrials.gov processed this record on March 26, 2015