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A Study of E7080 in Subjects With Solid Tumor

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. ) Identifier:
First received: December 28, 2010
Last updated: August 29, 2016
Last verified: August 2016
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

Condition Intervention Phase
Drug: E7080
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of E7080 in Subjects With Solid Tumor

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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).

Enrollment: 9
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01268293

Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Tatsuya Sasaki Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd. Identifier: NCT01268293     History of Changes
Other Study ID Numbers: E7080-J081-105
Study First Received: December 28, 2010
Results First Received: February 21, 2015
Last Updated: August 29, 2016

Keywords provided by Eisai Inc.:

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017