A Phase I Study of E7050 in Subjects With Solid Tumors

February 13, 2014 updated by: Eisai Co., Ltd.
The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan
    • Chiba
      • Kashiwa, Chiba, Japan
    • Shizuoka
      • Sunto, Shizuoka, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Aged from 20 to less than 75 years old at the time of obtaining informed consent.
  2. Histological or cytological diagnosis of solid tumors.
  3. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
  4. Adequate organ function.
  5. Subjects who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
  6. Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
  7. Expected to survive for 3 months or longer after starting administration of the investigational drug.

Exclusion Criteria

  1. Females who are pregnant or breastfeeding.
  2. Brain metastases with clinical symptoms or which requires treatment.
  3. Serious complications or disease history.
  4. Subjects who cannot take oral medication.
  5. Using antiplatelet/anticoagulant drugs.
  6. Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
  7. Scheduled for surgery during the study period.
  8. Known to be HIV, HBV or HCV positive.
  9. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of anti-psychotics or have had a suicide attempt(s) within approximately the last 2 years.
  10. History of drug or alcohol dependency or abuse within 2 years.
  11. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  12. Received any other investigational product or device within 4 weeks before administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E7050
Drug: E7050
Drug: E7050 The starting dose of E7050 will be 400 mg given orally, once-daily, in patients with advanced tumor that have progressed following effective therapy. The study consists of 2 parts: a Tolerability Confirmation Component to confirm the tolerable dose in subjects with solid tumor and an Expansion Component to confirm the safety and to preliminarily assess the anti-tumor activity in subjects with gastric cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the maximum tolerated dose (MTD)
Time Frame: During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment)
Determination of the MTD of E7050 given orally once daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT).
During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Hiroshi Obaishi, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 2, 2011

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7050-J081-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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