Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors
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