Patients with advanced solid tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Signed, written informed consent. - Histologically or cytologically confirmed solid tumor. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion criteria
Exclusion criteria: - Investigational drug therapy within 28 days prior to enrollment. - Radiotherapy within 21 days prior to enrollment. - Received extensive prior radiotherapy on more than 30% of bone marrow. - Females who are pregnant or breastfeeding. - Serious complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety CTCAE (ver.4.03) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, Efficacy RECIST (ver.1.1) | — |