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A Study of E7080 in Subjects With Solid Tumor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268293
First Posted: December 30, 2010
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
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
Cancer Drug: E7080 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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. ( Eisai Co., Ltd. ):

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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268293


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

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01268293     History of Changes
Other Study ID Numbers: E7080-J081-105
First Submitted: December 28, 2010
First Posted: December 30, 2010
Results First Submitted: February 21, 2015
Results First Posted: March 6, 2015
Last Update Posted: October 7, 2016
Last Verified: August 2016

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Cancer

Additional relevant MeSH terms:
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action