Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors

To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.

Inclusion Criteria:

• Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
• Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Other inclusion applies.

Exclusion Criteria:

• Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.
• Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for >= 2 weeks before day 1).
• Other exclusion applies.