Status:
COMPLETED
Phase 1 Study of E7090 in Subjects With Solid Tumor
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum ...
Eligibility Criteria
Inclusion
- Inclusion Criteria: Part 1and Part 2
- Provide written informed consent
- Male or female subjects age \>= 20 years at the time of informed consent
- Subjects with a histological and/or cytological diagnosis of solid tumor
- Subjects who failed standard therapies, or for which no appropriate treatment is available.
- Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
- Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
- Inclusion Criteria: Part 2 only
- Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.
- Exclusion criteria
- Patients with brain metastasis who have clinical symptoms or requiring treatment.
- Medical history of clinically significant cardiovascular impairment
- Concomitant systemic infection requiring medical treatment
- Effusion requiring drainage
- Known intolerance to the study drug (or any of excipients)
- Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
- 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.
- Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
- Females who are pregnant or breastfeeding
- Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.
Exclusion
Key Trial Info
Start Date :
October 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02275910
Start Date
October 28 2014
End Date
September 3 2021
Last Update
December 16 2025
Active Locations (18)
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1
Eisai Trial Site #1
Nagoya, Aichi-ken, Japan
2
Eisai Trial Site #1
Kashiwa, Chiba, Japan
3
Eisai Trial Site #1
Matsuyama, Ehime, Japan
4
Eisai Trial Site #1
Sapporo, Hokkaido, Japan