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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014