Solid tumor
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion criteria - Provided written informed consent - Histologically or cytologically confirmed solid tumor. - Has a lack of response to conventional therapy or no availability of generally acknowledged standard therapy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 - QTcF (QT corrected by Fridericia's correction): 450 msec and under - Women of childbearing potential must have a negative pregnancy test at baseline.
Exclusion criteria
Exclusion criteria: Key exclusion criteria - Has a serious illness or medical condition - Women who are pregnant, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety CTCAE (Ver.4.03) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics Efficacy, Pharmacokinetics RECIST (Ver.1.1) | — |
Countries
Japan