Solid Tumor
Conditions
Interventions
investigational material(s)
Generic name etc : E7090
INN of investigational material : -
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material :
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety other Safety and tolerability all measured Adverse Events and Serious Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| other - | — |
Countries
Japan
Outcome results
None listed