A Phase I, Multi-center, Open-label, Drug-drug Interaction Study to Assess the Effect of TKI258 on the Pharmacokinetics of Caffeine, Diclofenac, Omeprazole and Midazolam Administered as a Four-drug Cocktail in Patients With Advanced Solid Tumors, Excluding Breast Cancer

Inclusion Criteria:

- Patients with a cytopathologically or histopathologically confirmed diagnosis of an
advanced solid tumor, excluding breast cancer which has progressed despite standard
therapy or for which no standard therapy exists

- ECOG performance status 0 or 1 and anticipated life expectancy ≥ 3 months

- Patient must meet protocol-specific laboratory values

Exclusion Criteria:

- Patients with brain metastases

- Patients who have received or who are expected to receive any prohibited medications
and therapies

- Patients who have received CYP1A2 inducer, CYP2C9/2C19 inducer or CYP3A4 inducer
medications within 30 days prior to start study treatment or are expected to receive
during the first 14 days after starting the study treatment

- Patients with a known hypersensitivity to benzodiazepines

- Patients who have not recovered from previous anti-cancer therapies

- Patient with impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of TKI258

- Patients who have concurrent severe and/or uncontrolled concomitant medical
conditions that could compromise participation in the study

- Female patients who are pregnant or breast-feeding

- Fertile males or women not willing to use highly effective methods of contraception

- Other protocol-defined inclusion/exclusion criteria will apply