Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade

Inclusion Criteria:

• Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available
• Karnofsky Performance Status (KPS) equal to or greater than 70%
• Normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less than 2 x upper limit of normal [ULN])
• Total bilirubin equal to or less than 1.5 x ULN
• Calculated creatinine clearance equal to or greater than 50 mL/min
• Normal serum calcium

Exclusion Criteria:

• Patients with significant cardiac disease
• Equal to or greater than Grade 2 neuropathy
• Active hepatitis
• HIV infection
• Secondary malignancy
• Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment
• Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4