A Phase I Study of E7050 in Subjects With Solid Tumors
This study is currently recruiting participants.
Verified February 2013 by Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: September 1, 2011
Last updated: February 27, 2013
Last verified: February 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of E7050 in Subjects With Solid Tumors
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||20 Years to 74 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Aged from 20 to less than 75 years old at the time of obtaining informed consent.
- Histological or cytological diagnosis of solid tumors.
- Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
- Adequate organ function.
- 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.
- Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
- Expected to survive for 3 months or longer after starting administration of the investigational drug.
- Females who are pregnant or breastfeeding.
- Brain metastases with clinical symptoms or which requires treatment.
- Serious complications or disease history.
- Subjects who cannot take oral medication.
- Using antiplatelet/anticoagulant drugs.
- Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
- Scheduled for surgery during the study period.
- Known to be HIV, HBV or HCV positive.
- 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.
- History of drug or alcohol dependency or abuse within 2 years.
- Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- Received any other investigational product or device within 4 weeks before administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428141
|Nagoya, Aichi, Japan |
|Kashiwa, Chiba, Japan |
|Sunto, Shizuoka, Japan |
Eisai Co., Ltd.
||Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
No publications provided
||Eisai Inc. ( Eisai Co., Ltd. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2011
||February 27, 2013
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by Eisai Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases