Status:
COMPLETED
A Phase I Study of E7050 in Subjects With Solid Tumors
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Solid Tumor
Gastric Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01428141
Start Date
September 1 2011
End Date
July 1 2013
Last Update
February 14 2014
Active Locations (3)
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1
Nagoya, Aichi-ken, Japan
2
Kashiwa, Chiba, Japan
3
Sunto, Shizuoka, Japan