Advanced Solid Tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed solid tumor -Advanced cancer that did not respond to the standard therapy or for which a standard therapy has not been established -PS of 0 to 1
Exclusion criteria
Exclusion criteria: -Patients in whom an adverse reaction to the previous treatment persists at Grade 2 or higher. -Patients with metastasis to the central nervous system that is accompanied by symptoms or requires treatment -Clinically significant inflammatory condition is observed on the ocular surface
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD, Safety, Pharmacokinetics NCI-CTCAE ver. 3.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics, tumor response RECIST Ver. 1 | — |