JPRN-jRCT2080221558
Unknown
Phase 1
A phase I study of E7050 in subjects with solid tumors
Conditionssolid tumor, gastric cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- solid tumor, gastric cancer
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 33
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged from 20 to less than 75 years old at the time of obtaining informed consent.
- •2\. Histological or cytological diagnosis of solid tumors.
- •3\. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
- •4\. Adequate organ function.
- •5\. 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.
- •6\. Performance Status (PS) 0\-1 established by Eastern Cooperative Oncology Group (ECOG).
- •7\. Expected to survive for 3 months or longer after starting administration of the investigational drug.
Exclusion Criteria
- •1\. Females who are pregnant or breast feeding.
- •2\. Brain metastases with clinical symptoms or which requires treatment.
- •3\. Serious complications or disease history.
- •4\. Subjects who cannot take oral medication.
- •5\. Using antiplatelet/anticoagulant drugs.
- •6\. Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
- •7\. Scheduled for surgery during the study period.
- •8\. Known to be HIV, HBV or HCV positive.
- •9\. 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.
- •10\. History of drug or alcohol dependency or abuse within 2 years.
Outcomes
Primary Outcomes
Not specified
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