A Phase I Study of E7050 in Subjects With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01428141
First received: September 1, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Solid Tumor
Gastric Cancer
Drug: E7050
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 I Study of E7050 in Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Determination of the maximum tolerated dose (MTD) [ Time Frame: During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment) ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 18
Study Start Date: September 2011
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01428141

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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01428141     History of Changes
Other Study ID Numbers: E7050-J081-110
Study First Received: September 1, 2011
Last Updated: February 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer
Gastrointestinal Cancer

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

ClinicalTrials.gov processed this record on July 28, 2014