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
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:
  • 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 ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01268293     History of Changes
Other Study ID Numbers: E7080-J081-105
Study First Received: December 28, 2010
Last Updated: February 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer

ClinicalTrials.gov processed this record on April 17, 2014