A Phase I Study of E7050 in Subjects With Solid Tumors

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.