Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment.
Exclusion criteria
Exclusion criteria: Subjects with symptomatic brain metastasis or active brain metastasis requiring treatments. Inability to swallow oral medication. Uncontrolled or significant cardiovascular disease. Inadequate bone marrow function. Inadequate hepatic function. Inadequate renal function. Pancreatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose Limiting Toxicity (DLT) and observed adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of subjects experienced DLT. PK parameters (Cmax, Cmin, Tmax, AUC(TAU), T-half,eff, AI). Best overall response. | — |