Solid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically diagnosis of solid tumor Patients with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available Patients with adequate organ functions Patients with 0 to 1 of ECOG Performance Status (P.S.) score Patients with 12 weeks or more life expectancy and so on
Exclusion criteria
Exclusion criteria: Patients with the severe complication Patients with brain metastasis accompanying clinical symptoms Patients with hematopoietic tumor Patients with active infections in need of treatment for systemic and so on
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) CTCAE ver.4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and anti-tumor activity RECIST ver.1.1, Drug concentration measurement | — |