Study Evaluating SKI-606 in Subject With Solid Tumors

Inclusion criteria

• Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
• Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
• Adequate hepatic, renal, and bone marrow function
• Age 20 to 74 years
• Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
• Life expectancy of at least 12 weeks

Exclusion criteria

• Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
• Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
• Prior exposure to SKI-606 or any other Src-kinase inhibitor
• Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
• Subjects unable or unwilling to swallow SKI-606 capsules
• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
• Recent or ongoing clinically-significant gastrointestinal disorder
• Pregnant or breastfeeding women
• Subjects who meet the following criteria:

• Evidence of serious active infection, significant medical or psychiatric illness
• History of unexplained syncope or known ventricular arrythmia
• Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
• Hypokalemia
• Unstable concurrent medical conditions
• Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study