Solid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Signed written informed consent Solid tumors to be unresponsive to, or untreatable by standard therapies Three-month or more life expectancy Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2
Exclusion criteria
Exclusion criteria: Hematologic abnormality Myocardial infarction or clinically symptomatic left ventricular failure Active hypertension or controllable hypertension more than 3 antihypertensive medications Symptomatic CNS metastasis Unhealed wounds Active infections Hepatic or renal functional disorder Any of the HBs antigen, HCV antibody and HIV antibody positivity Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug Pregnant or lactating women Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the maximum tolerated dose (MTD) of KRN951 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and anti-tumor activity | — |