Lead Sponsor

Nerviano Medical Sciences

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

•1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
•2. Maximum of 4 regimens of prior cancer therapy allowed
•3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
•4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
•5. ECOG performance status (PS) 0 or 1
•6. Adult (age \>/= 18 and \</= 80 years) patients
•7. Adequate renal, liver and BM reserve
•8. Capability to swallow capsules intact

•1. Current enrollment in another therapeutic clinical trial
•2. Known brain metastases
•3. Currently active second malignancy
•4. Major surgery within 4 weeks prior to treatment
•5. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
•6. Pregnancy or breast-feeding women
•7. Known active infections
•8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
•9. Adrenal insufficiency
•10. Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives