A Study of E7080 in Subjects With Solid Tumor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01268293
First received: December 28, 2010
Last updated: February 13, 2014
Last verified: February 2014

December 28, 2010
February 13, 2014
February 2011
December 2011   (final data collection date for primary outcome measure)
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 ]
To investigate the number of subjects with adverse events [ Time Frame: Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01268293 on ClinicalTrials.gov Archive Site
Not Provided
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A Study of E7080 in Subjects With Solid Tumor
A Phase 1 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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
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.
Experimental: 1
Intervention: Drug: E7080
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
April 2013
December 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01268293
E7080-J081-105
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Tatsuya Sasaki Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Eisai Inc.
February 2014

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