Phase 1 Study of E7090 in Subjects With Solid Tumor

Eisai Co., Ltd.0 sites40 target enrollmentDecember 11, 2014

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2014

End Date

March 24, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Provide written informed consent
•2\.Male or female subjects age \>\= 20 years at the time of informed consent
•3\.Subjects with a histological and/or cytological diagnosis of solid tumor
•4\.Subjects who failed standard therapies, or for which no appropriate treatment is available.
•5\.Subjects with Performance Status (PS) score of 0\-1 established by Eastern Cooperative Oncology Group (ECOG)
•6\.Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
•7\.Subjects with tumor expressing genetic abnormality in FGF/FGFR.

•1\.Patients with brain metastasis who have clinical symptoms or requiring treatment.
•2\.Medical history of clinically significant cardiovascular impairment
•3\.Concomitant systemic infection requiring medical treatment
•4\.Effusion requiring drainage
•5\.Known intolerance to the study drug (or any of excipients)
•6\.Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
•7\.Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090\.
•8\.Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
•9\.Females who are pregnant or breastfeeding
•10\.Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.