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A Phase I Study of E7050 in Subjects With Solid Tumors

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. Identifier: NCT01428141
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Gastric Cancer Drug: E7050 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of E7050 in Subjects With Solid Tumors
Study Start Date : September 2011
Primary Completion Date : January 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01428141

Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Sunto, Shizuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Hiroshi Obaishi Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.

Responsible Party: Eisai Co., Ltd. Identifier: NCT01428141     History of Changes
Other Study ID Numbers: E7050-J081-110
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases